Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-29 @ 1:53 AM
Study NCT ID:
NCT06242392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of PARP inhibitors in the treatment of ovarian cancer', 'timeFrame': '2026-5-1', 'description': 'Progression-Free Survival (PFS) is used to evaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.'}], 'secondaryOutcomes': [{'measure': 'cost-effectiveness analysis of using PARP inhibitors to treat cervical cancer', 'timeFrame': '2026-5-1', 'description': 'The main economic outcome is the ICER.Health benefits were expressed as life years (LYs), and quality-adjusted life-years (QALYs) gained. The ICER was calculated by dividing the incremental cost difference between the two strategies, by the incremental difference in health outcomes (LYs and QALYs). Probabilistic Sensitivity Analysis (PSA) was performed to assess the impact of uncertainty around the key parameters of the model on the ICER. A second-order Monte Carlo simulation with 1000 iterations was used to run replicated outcomes. The normal distributions used for costs, utility and reimbursement ratio were carried to the specific limits.'}, {'measure': 'PARP inhibitors in the treatment of ovarian cancer', 'timeFrame': '2026-5-1', 'description': 'Overall survival (OS) was used toevaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian Neoplasms', 'homologous recombination deficiency', 'prognosis', 'Cost-effectiveness analysis'], 'conditions': ['Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '33004253', 'type': 'BACKGROUND', 'citation': 'Miller RE, Leary A, Scott CL, Serra V, Lord CJ, Bowtell D, Chang DK, Garsed DW, Jonkers J, Ledermann JA, Nik-Zainal S, Ray-Coquard I, Shah SP, Matias-Guiu X, Swisher EM, Yates LR. ESMO recommendations on predictive biomarker testing for homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020 Dec;31(12):1606-1622. doi: 10.1016/j.annonc.2020.08.2102. Epub 2020 Sep 28.'}, {'pmid': '34861371', 'type': 'BACKGROUND', 'citation': "Vergote I, Gonzalez-Martin A, Ray-Coquard I, Harter P, Colombo N, Pujol P, Lorusso D, Mirza MR, Brasiuniene B, Madry R, Brenton JD, Ausems MGEM, Buttner R, Lambrechts D; European experts' consensus group. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer. Ann Oncol. 2022 Mar;33(3):276-287. doi: 10.1016/j.annonc.2021.11.013. Epub 2021 Dec 1."}, {'pmid': '30910306', 'type': 'BACKGROUND', 'citation': 'Lheureux S, Gourley C, Vergote I, Oza AM. Epithelial ovarian cancer. Lancet. 2019 Mar 23;393(10177):1240-1253. doi: 10.1016/S0140-6736(18)32552-2.'}, {'pmid': '36788098', 'type': 'BACKGROUND', 'citation': 'Doig KD, Fellowes AP, Fox SB. Homologous Recombination Repair Deficiency: An Overview for Pathologists. Mod Pathol. 2023 Mar;36(3):100049. doi: 10.1016/j.modpat.2022.100049. Epub 2023 Jan 10.'}, {'pmid': '31851799', 'type': 'BACKGROUND', 'citation': 'Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.'}, {'pmid': '35017033', 'type': 'BACKGROUND', 'citation': 'Moore KN, du Bois A. Homologous recombination deficiency testing in first-line ovarian cancer. Ann Oncol. 2022 Mar;33(3):231-233. doi: 10.1016/j.annonc.2021.12.013. Epub 2022 Jan 8. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Clinicopathological data were collected from ovarian cancer patients treated with PARP inhibitors, with follow-up imaging conducted before and after treatment. The efficacy was evaluated according to RECIST criteria, comparing the correlation between different HRD statuses and the efficacy of PARP inhibitors in ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Ovarian Cancer who were treated from June 2020 to December 2026 and met the above inclusion and exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with ovarian cancer (any histological type) and possessing complete pathological hematoxylin and eosin (HE) stained slides and paraffin-embedded tissue blocks.\n* Patients must be 18 years of age or older.\n* Patients should not have concurrent multiple primary cancers.\n* Patients must undergo an MRI or CT scan prior to starting treatment.\n* According to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, patients must have at least one measurable lesion.\n* Participants must provide informed consent, voluntarily cooperate with clinical follow-up, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Patients who do not have accessible tumor tissue required for Homologous Recombination Deficiency (HRD) testing.\n* Patients whose clinical records are incomplete, making it impossible to effectively compare treatment efficacy.\n* Patients who are lost to follow-up and for whom subsequent treatment outcomes cannot be tracked.'}, 'identificationModule': {'nctId': 'NCT06242392', 'briefTitle': 'The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'The Correlation Between Homologous Recombination Deficiency Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer', 'orgStudyIdInfo': {'id': 'ChenJian2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'effective group', 'description': 'The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria, patients who were evaluated as complete remission, partial remission and stable disease were included in the effective group. Patients assessed as having progressive disease were included in the treatment-refractory group.', 'interventionNames': ['Genetic: homologous recombination deficiency']}, {'label': 'ineffective group', 'description': 'The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria. Patients assessed as having progressive disease were included in the ineffective group.', 'interventionNames': ['Genetic: homologous recombination deficiency']}], 'interventions': [{'name': 'homologous recombination deficiency', 'type': 'GENETIC', 'description': 'Homologous Recombination Deficiency (HRD) refers to a disruption or deficiency in the homologous recombination repair (HRR) pathway, which is a crucial mechanism in cells for repairing DNA double-strand breaks (DSBs). This pathway is particularly important for maintaining genomic stability.', 'armGroupLabels': ['effective group', 'ineffective group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jian FC Chen', 'role': 'CONTACT', 'email': 'marsz3@126.com', 'phone': '+8615806030009'}, {'name': 'Yang Sun', 'role': 'CONTACT', 'email': 'doctorsunyang@sina.com', 'phone': '15959028989'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}