Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05328258
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2022-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of GnRHa During Chemotherapy for Fertility Protection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012512', 'term': 'Sarcoma, Ewing'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Subjects are randomised to triptorelin (active arm) or placebo (control) given in parallel to the chemotherapy treatment for the cancer diagnosis. All personnel involved in the study, and subjects, except personnel preparing triptorelin/placebo at the local site and an unblinded monitor, will be blinded during the study. Unblinded research nurse at each site will prepare blinded triptorelin/placebo to subjects and a web-based randomisation system will be used to allocate of blinded triptorelin/placebo to subjects at randomisation and drug dispense during the treatment period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomised, double-blinded, placebo-controlled, phase 3 study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2032-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-Müllerian Hormone (AMH) levels in women with breast cancer', 'timeFrame': '12 months after end of gonadotoxic chemotherapy and study drug treatment', 'description': 'To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Anti-Müllerian Hormone (AMH) levels in women with acute leukemias, lymphomas and sarcomas.', 'timeFrame': '12 months after end of gonadotoxic chemotherapy and study drug treatment', 'description': 'To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH relative to AMH levels at EoT in women with acute leukemias, lymphomas and sarcomas.'}, {'measure': 'Changes in ovarian reserve with or without Gonadotropin-Releasing Hormone agonist (GnRHa) by determination of the antral follicle counts (AFC)', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and at 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT', 'description': 'Changes in AFC in women with breast cancer and with acute leukemia, lymphoma and sarcoma respectively'}, {'measure': 'Changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels', 'timeFrame': 'At 6 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'The difference in recovery of AMH levels between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively'}, {'measure': 'The proportion of females with or without GnRHa that develop ovarian insufficiency by determination of follicle stimulating hormone (FSH), inhibin and estradiol', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of FSH, inhibin and estradiol between the GnRHa group and the placebo group'}, {'measure': 'Impact of body mass index (BMI) (Kg/m2) on changes in ovarian reserve with or without GnRHa', 'timeFrame': 'At Baseline, during treatment, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'longitudinal observation of AMH levels, FSH, inhibin and estradiol'}, {'measure': 'Impact of use of contraceptives (yes/no) in changes of ovarian reserve with or without GnRHa', 'timeFrame': 'At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'longitudinal observation of AMH levels, FSH, inhibin and estradiol'}, {'measure': 'Impact of endocrine adjuvant therapy (yes/no) in changes of ovarian reserve with or without GnRHa', 'timeFrame': 'At Baseline, during treatment visits (every 1-3 months of gonadotoxic treatment), at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'longitudinal observation of AMH levels, FSH, inhibin and estradiol'}, {'measure': 'The effect of GnRHa with or without GnRHa on ovarian blood supply', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of blood flow to the ovarian artery (right and left Doppler flow) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively'}, {'measure': 'The proportion of females with or without GnRHa that develop amenorrhea (no menstruations)', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of the proportion that develop amenorrhea (no menstruations) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively'}, {'measure': 'Pregnacy wish after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of of pregnancy wish (Study specific questionaire) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up', 'timeFrame': 'At end of chemotherapy (corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of pregnancy attempts (Study specific questionaire) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of pregnancy outcome between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Health-related quality of life (EORTC QLQ C30)', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of validated outcome on health-related QoL (EORTC QLQ C30) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Health-related quality of life (FSFI)', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of validated outcome of sexuality and reproductive health (Female Sexual Function Index (FSFI)) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Health-related quality of life (HAD)', 'timeFrame': 'At end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months), and 6 months, 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Comparison of validated outcome on health-related QoL (Hospital Anxiety and Depression Scale (HAD)) between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'The development of co-morbidities during follow-up and bone mineral density', 'timeFrame': 'At baseline, at end of gonadotoxic chemotherapy (EoT; corresponding to Baseline+2-11 months) and 12 months and 5 years after EoT', 'description': 'Comparison of bone mineral density between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Disease-specific oncologic outcomes: disease-free survival', 'timeFrame': 'At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Investigation of disease-free survival between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Disease-specific oncologic outcomes: Recurrence rate', 'timeFrame': 'At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Investigation of recurrence rate between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}, {'measure': 'Disease-specific oncologic outcomes: overall survival', 'timeFrame': 'At 12 months, 2 years, 3 years, 4 years and 5 years after EoT.', 'description': 'Investigation of overall survival between the GnRHa group and the placebo group in women with breast cancer and in women with acute leukemia, lymphoma and sarcoma respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fertility protection of young women receiving chemotherapy'], 'conditions': ['Breast Cancer Female', 'Acute Leukemia', 'Lymphoma', 'Osteosarcoma', 'Soft Tissue Sarcoma', 'Ewing Sarcoma']}, 'referencesModule': {'references': [{'pmid': '38070906', 'type': 'DERIVED', 'citation': 'Rodriguez-Wallberg KA, Nilsson HP, Bergh J, Malmros J, Ljungman P, Foukakis T, Stragliotto CL, Friman EI, Linderholm B, Valachis A, Andersson A, Harrysson S, Vennstrom L, Frisk P, Morse H, Eloranta S. ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden-a phase III randomised double-blinded placebo-controlled study. BMJ Open. 2023 Dec 9;13(12):e078023. doi: 10.1136/bmjopen-2023-078023.'}]}, 'descriptionModule': {'briefSummary': 'Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects.\n\nApproximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment.\n\nThe patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection.\n\nPatients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '42 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy\n* Confirmed menarche\n* ECOG performance status 0-1\n* Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders\n\nExclusion Criteria:\n\n* Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data\n* Previous or planned bilateral oophorectomy\n* Pregnancy or breastfeeding at time of start of chemotherapy\n* Other malignancy diagnosed within the last five years\n* Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia\n* Known osteoporosis\n* Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias\n* Known or suspected allergy against triptorelin\n* Direct radiation of the gonads previous or planned (TBI allowed)\n* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation'}, 'identificationModule': {'nctId': 'NCT05328258', 'acronym': 'ProFertil', 'briefTitle': 'Use of GnRHa During Chemotherapy for Fertility Protection', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'A Phase 3 Randomised Double-Blinded Placebo-Controlled Study of Use of GnRHa During Chemotherapy for Fertility Protection of Young Women and Teenagers With Cancer', 'orgStudyIdInfo': {'id': 'ProFertil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Triptorelin', 'description': 'Triptorelin given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment.\n\nThe dose is ether 11.25 mg triptorelin given for subjects having at least 3 months gonadotoxic treatment, OR 3.75 mg for subjects during one-month of gonadotoxic treatment', 'interventionNames': ['Drug: Triptorelin Embonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B: Placebo', 'description': "Placebo, 0.9% sodium chloride, given intramuscularly once every month or every third month during gonadotoxic chemotherapy treatment.\n\nThe dose will be provided both as one injection compensating for 3 months' effect and one injection compensating for 1 month' effect to maintain the study blind.", 'interventionNames': ['Drug: Sodium Chloride solution 0.9%']}], 'interventions': [{'name': 'Triptorelin Embonate', 'type': 'DRUG', 'otherNames': ['Pamorelin'], 'description': "11.25 mg will be given for subjects having at least 3 months gonadotoxic treatment, one injection of 11.25 mg will compensate for 3 months' effect of the study drug.\n\n3.75 mg will be given for subjects during one-month of gonadotoxic treatment, one injection of 3.75 mg will compensate for 1 month' effect of the study drug.", 'armGroupLabels': ['Arm A: Triptorelin']}, {'name': 'Sodium Chloride solution 0.9%', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': "One injection compensating for 3 months' effect OR one injection compensating for 1 month' effect to maintain the study blind.", 'armGroupLabels': ['Arm B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Karin Mellgren', 'role': 'CONTACT'}], 'facility': 'Center for Pediatric Cancer, Queen Silvia Hospital for Children and Youth', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Per Frisk', 'role': 'CONTACT'}], 'facility': 'Center for Pediatric Oncology, Akademiska Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Barbro Linderholm', 'role': 'CONTACT'}], 'facility': 'Department of Oncology, Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Lund', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Niklas Loman', 'role': 'CONTACT'}], 'facility': 'Department of Hematology, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Lund', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Mats Jerkerman', 'role': 'CONTACT'}], 'facility': 'Department of Oncology, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Lund', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Helena Mörse', 'role': 'CONTACT'}], 'facility': 'Department of Pediatric Oncology, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Örebro', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Sweden', 'facility': 'Department of Oncology, Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '17176', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Theo Foukakis, MD, PhD', 'role': 'CONTACT', 'email': 'theo.foukakis@ki.se'}], 'facility': 'Karolinska Univeristy Hospital, Breast Centre', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Lovisa Vennström', 'role': 'CONTACT'}], 'facility': 'Department of Hematology and coagulation, Sahlgrenska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Barbro Kedinge', 'role': 'CONTACT'}], 'facility': 'Department of Hematology, Capio ST. Göran Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Annelie Liljegren', 'role': 'CONTACT'}], 'facility': 'Department of Internal Medicine, Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Erika Isaksson Friman', 'role': 'CONTACT'}], 'facility': 'Department of Oncology, Capio ST. Göran Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christina Linder-Stragliotto', 'role': 'CONTACT'}], 'facility': 'Department of Oncology, Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Per Ljungman', 'role': 'CONTACT'}], 'facility': 'Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sara Harrysson, MD, PhD', 'role': 'CONTACT', 'email': 'sara.harrysson@regionstockholm.se'}], 'facility': 'Karolinska University Hospital, Hematology', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johan Malmros, MD, PhD', 'role': 'CONTACT', 'email': 'johan.malmros@ki.se'}], 'facility': 'Karolinska University Hospital, High Specialised Pediatric Medicine', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anne Andersson', 'role': 'CONTACT'}], 'facility': 'Department of Oncology, Norrlands University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'centralContacts': [{'name': 'Kenny Rodriguez Wallberg, MD, PhD', 'role': 'CONTACT', 'email': 'kenny.rodriguez-wallberg@ki.se', 'phone': '+46 858580000'}, {'name': 'Hanna Nilsson, PhD', 'role': 'CONTACT', 'email': 'hanna.nilsson@ki.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The identity of the individual participants is protected by GDPR through the The Swedish Authority for Privacy Protection as regulated by the informed consent and any data sharing must be in accordance with their regulations. We can thus only share IPD that underlie the results reported in this study (text, tables, figures, and appendices), after full anonymization of the data.\n\nAfter completion of the study the protocol, informed consent form and statistical analysis plan will be available.\n\nRequests for additional analyses or to access the anonymized datasets should be directed to kenny.rodriguez-wallberg@ki.se. Information will be available upon reasonable request to the sponsor and if in correspondence with the proposed research in the signed informed consent e.g to achieve aims in the approved proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kenny Rodriguez-Wallberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Adjunct professor', 'investigatorFullName': 'Kenny Rodriguez-Wallberg', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}