Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-01 @ 11:05 AM
Study NCT ID:
NCT06605404
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pan-tumor MRD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood and tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood and tissue biospecimen registry', 'timeFrame': 'Observation from enrollment to 5.5 years after enrollment', 'description': 'To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['observational', 'biospecimen', 'routine care'], 'conditions': ['Muscle Invasive Bladder Urothelial Carcinoma', 'Esophageal Cancer', 'Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Melanoma (Skin Cancer)', 'NSCLC (Non-small Cell Lung Cancer)', 'Pancreatic (Exocrine Only)', 'Mix of Solid Tumors (MOST)']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.\n\nParticipants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors', 'genderDescription': 'Gender as defined at birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria:\n\n1. Age 18 years or older.\n2. Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).\n3. Eligible for curative intent therapy, with surgical resection of cancer planned.\n\n a. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.\n5. No systemic therapy for current cancer diagnosis administered before enrollment.\n6. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.\n7. Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ malignancy (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no washout period required).\n8. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.\n9. No prior allogeneic hematopoietic stem cell transplant.\n10. Able and willing to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information.\n\n Cohort Specific Criteria\n11. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:\n12. Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.\n13. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.\n14. MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts.\n\nThe following tumor types are excluded:\n\n1. Central nervous system (CNS) malignancies\n2. Colorectal cancer\n3. Breast cancer\n4. Squamous cell skin cancer\n5. Basal cell carcinoma\n6. Gastrointestinal stromal tumors (GIST)\n7. Thyroid cancer\n8. Uveal melanoma\n9. Low or intermediate grade neuroendocrine tumors\n\n ■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible\n10. Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin\\'s lymphoma, non-Hodgkin\\'s lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia / small lymphocytic leukemia'}, 'identificationModule': {'nctId': 'NCT06605404', 'briefTitle': 'Pan-tumor MRD Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Flatiron Health'}, 'officialTitle': 'Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers', 'orgStudyIdInfo': {'id': 'FH-PrwS-07-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)', 'description': 'Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}, {'label': 'Esophageal', 'description': 'Esophageal cancer', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}, {'label': 'Gastric and Gastroesophageal Junction (GEJ)', 'description': 'Gastric and Gastroesophageal Junction (GEJ)', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}, {'label': 'Melanoma', 'description': 'Melanoma', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}, {'label': 'Non-small cell lung (NSCLC)', 'description': 'Non-small cell lung (NSCLC)', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}, {'label': 'Pancreatic (exocrine only)', 'description': 'Pancreatic (exocrine only)', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}, {'label': 'Mix of Solid Tumors (MOST)', 'description': 'Mix of Solid Tumors (MOST)', 'interventionNames': ['Diagnostic Test: blood and tissue samples', 'Other: blood and tissue samples']}], 'interventions': [{'name': 'blood and tissue samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'routine standard of care', 'armGroupLabels': ['Esophageal', 'Gastric and Gastroesophageal Junction (GEJ)', 'Melanoma', 'Mix of Solid Tumors (MOST)', 'Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)', 'Non-small cell lung (NSCLC)', 'Pancreatic (exocrine only)']}, {'name': 'blood and tissue samples', 'type': 'OTHER', 'description': 'Routine standard of care', 'armGroupLabels': ['Esophageal', 'Gastric and Gastroesophageal Junction (GEJ)', 'Melanoma', 'Mix of Solid Tumors (MOST)', 'Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)', 'Non-small cell lung (NSCLC)', 'Pancreatic (exocrine only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexis Bustamante', 'role': 'CONTACT', 'email': 'abustamante@oncologysandiego.com'}], 'facility': 'Medical Oncology Associates of San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '43437', 'city': 'Maumee', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Martinez', 'role': 'CONTACT', 'email': 'jmartinez@toledoclinic.com', 'phone': '419-479-5605', 'phoneExt': 'ext 4134'}], 'facility': 'Taylor Cancer Research Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}], 'centralContacts': [{'name': 'Anosheh Afghahi, MD', 'role': 'CONTACT', 'email': 'anosheh.afghahi@flatiron.com', 'phone': '888-662-6367'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flatiron Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}