Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-08 @ 11:16 AM
Study NCT ID:
NCT02732860
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland 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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood, formalin fixed paraffin embedded blocks, fresh tumor tissue, malignant effusion or ascites (if no tumor tissue available), archival tissue (if not enrolled in molecular profiling studies IMPACT/OCTANE)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of drug sensitive pPDX to a panel of drugs as a predictor of clinical response in matched host', 'timeFrame': 'up to 5 years', 'description': 'Sensitivity measured by tumor growth inhibition (\\>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.'}, {'measure': 'Rate of results reporting', 'timeFrame': 'up to 5 years'}, {'measure': 'Rate of pPDX engraftment', 'timeFrame': 'up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Comparison of actionable alterations identified in clinical and pPDX samples', 'timeFrame': 'up to 5 years', 'description': 'Genomic alterations identified using the Ion Proton System for Next-Generation Sequencing (NGS).'}, {'measure': 'Number of patients with molecular abnormalities in pPDX as identified via NGS eliciting clinical responses while receiving matched treatments.', 'timeFrame': 'up to 5 years', 'description': 'Overall accuracy of clinical responses as assessed by RECIST criteria in patient tumor.'}, {'measure': 'Correlation between pPDX and organoid drug sensitivities', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['personalized patient-derived xenografts (pPDX)', 'molecular profiling', 'epigenetic analysis', 'drug sensitivity testing', 'triple negative', 'metastatic', 'serous'], 'conditions': ['Colorectal Neoplasms', 'Colorectal Cancer', 'Breast Cancer', 'Breast Neoplasms', 'Ovarian Cancer', 'Ovarian Neoplasm']}, 'descriptionModule': {'briefSummary': 'By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options', 'detailedDescription': 'Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with TNBC, CRC, HGSOC, or selected other tumour types, referred to, or being treated at Princess Margaret Cancer Centre.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):\n\n (I) Histologically confirmed Triple Negative Breast Cancer by Institutional and American Society of Clinical Oncology (ASCO)/Cancer of American Pathologists (CAP) guidelines, either:\n * Stage IV (metastatic) disease that has not been treated with systemic therapy in the metastatic setting or\n * Stage I to III (non-metastatic) with residual mass by clinical exam and/or breast imaging following anthracycline + taxane-containing neoadjuvant chemotherapy\n\n OR\n\n (II) Histologically-confirmed Stage IV colorectal cancer treated with ≤ 1 line of systemic therapy in the metastatic setting, either:\n * Undergoing surgical resection of liver metastases or\n * With metastatic lesions amenable to biopsy\n\n OR\n\n (III) Histologically-confirmed advanced High Grade Serous Ovarian Cancer, either:\n * Recurrent disease with a life expectancy of at least 12 months or\n * Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence\n\n OR\n\n (IV) Histologically confirmed solid tumor not meeting criteria for (I), (II) or (III) above, for which evaluation of investigational therapies is of particular interest or where clinical need exists, at the discretion of the PI\n3. Disease amenable to biopsy or surgery for tissue procurement\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n5. Willingness and ability of patient to provide signed voluntary informed consent.\n\nExclusion Criteria:\n\n1. Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials.\n2. Known brain metastasis\n3. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.\n4. Any contraindication to undergoing a biopsy procedure."}, 'identificationModule': {'nctId': 'NCT02732860', 'acronym': 'REFLECT', 'briefTitle': 'Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host', 'orgStudyIdInfo': {'id': 'REFLECT-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Triple Negative Breast Cancer', 'description': 'Triple negative breast cancer patients with residual invasive disease following neoadjuvant chemotherapy (n= up to 15) or with newly diagnosed metastatic disease (n=up to 30).\n\nAfter the screening procedures confirms patient eligibility:\n\n* Molecular Profiling will be performed on clinical sample\n* pPDX generation for in vivo drug testing\n* In vitro organoid culture generation (if sufficient fresh tissue available)\n* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.', 'interventionNames': ['Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures']}, {'label': 'Colorectal Cancer', 'description': 'Colorectal cancer patients with metastatic disease undergoing resection of liver metastases, or with lesions amenable to biopsy (n=up to 15).\n\nAfter the screening procedures confirms patient eligibility:\n\n* Molecular Profiling will be performed on clinical sample\n* pPDX generation for in vivo drug testing\n* In vitro organoid culture generation (if sufficient fresh tissue available)\n* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.', 'interventionNames': ['Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures']}, {'label': 'High Grade Serous Ovarian Cancer', 'description': 'High grade serous ovarian cancer patients with recurrent disease with a life expectancy of at least 12 months (n=up to 15), or Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence (n=up to 15).\n\nAfter the screening procedures confirms patient eligibility:\n\n* Molecular Profiling will be performed on clinical sample\n* pPDX generation for in vivo drug testing\n* In vitro organoid culture generation (if sufficient fresh tissue available)\n* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.', 'interventionNames': ['Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures']}, {'label': 'Other tumor types', 'description': 'Other selected tumor types at the discretion of the PI (n= up to 30)\n\nAfter the screening procedures confirms patient eligibility:\n\n* Molecular Profiling will be performed on clinical sample\n* pPDX generation for in vivo drug testing\n* In vitro organoid culture generation (if sufficient fresh tissue available)\n* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.', 'interventionNames': ['Other: Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures']}], 'interventions': [{'name': 'Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures', 'type': 'OTHER', 'description': 'Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.', 'armGroupLabels': ['Colorectal Cancer', 'High Grade Serous Ovarian Cancer', 'Other tumor types', 'Triple Negative Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Elizabeth Shah', 'role': 'CONTACT', 'email': 'elizabeth.shah@uhn.ca', 'phone': '416-946-4501', 'phoneExt': '3833'}, {'name': 'David Cescon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'David Cescon, MD', 'role': 'CONTACT', 'email': 'Dave.Cescon@uhn.ca', 'phone': '416-946-2245'}], 'overallOfficials': [{'name': 'David Cescon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}