Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-09 @ 4:09 AM
Study NCT ID:
NCT03023202
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2017-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UWCCC Molecular Tumor Board Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Subjects will be asked to give one blood sample and up to two tissue samples (one at diagnossi \\& one at progression of treatment, which are both standard clinical procedures).\n\n* Drawing 8 tsp of blood at the first clinic visit, DNA extraction from this blood, additional testing on this blood.\n* Retention of residual tumor tissue for future research.\n* Collection of residual fresh tumor tissue \\[that was biopsied for clinical reasons\\], and performing of genetic analyses/retention for future research.\n* Banking of data, blood, and biopsy tissue for future research.\n* Distribution of banked data/blood/biopsied tissue for research projects.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of acceptance of molecular tumor board recommendations', 'timeFrame': 'Up to 5 years', 'description': "How often the molecular tumor board's recommendations are accepted"}, {'measure': 'Benefit from PMMTB recommended treatment', 'timeFrame': 'Up to 5 years', 'description': 'Whether patients benefit from PMMTB recommended treatment'}], 'secondaryOutcomes': [{'measure': 'Correlation of mutations with protein overexpression', 'timeFrame': 'Up to 5 years', 'description': 'Correlate mutations identified in tumor tissue with protein overexpression'}, {'measure': 'Correlations of mutations with circulating tumor DNA', 'timeFrame': 'Up to 5 years', 'description': 'Correlate mutations identified in tumor tissue with circulating tumor DNA'}, {'measure': 'Correlations of mutations with spheroid culture investigations', 'timeFrame': 'Up to 5 years', 'description': 'Correlate mutations identified in tumor tissue with spheroid culture investigations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Neoplasms', 'Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'UW Carbone Cancer Center Home Page'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor Board, and to track patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include all patients age ≥18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor. It will require each patient to have the ability to understand and willingness to sign a written informed consent document.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically suspected or histologically confirmed solid or hematological malignancy\n* Undergoing genetic testing of tumor\n* Ability to understand written informed consent document\n* Willingness to sign written informed consent document\n\nExclusion Criteria:\n\n* Pediatric patients (age\\<18 years) will be excluded due to a lack of expertise on the molecular tumor committee'}, 'identificationModule': {'nctId': 'NCT03023202', 'briefTitle': 'UWCCC Molecular Tumor Board Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'UWCCC Precision Medicine Molecular Tumor Board Registry', 'orgStudyIdInfo': {'id': 'UW15068'}, 'secondaryIdInfos': [{'id': 'P30CA014520', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014520', 'type': 'NIH'}, {'id': '1R37CA226526-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R37CA226526-01A1', 'type': 'NIH'}, {'id': 'NCI-2019-06343', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': '2015-1370', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A533400', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\UWCCC\\GENERAL', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 3/24/24', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PMMTB', 'description': 'This study of the PMMTB will include all patients \\>= 18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor.\n\nAll standard of care functions will be performed by standard procedures.', 'interventionNames': ['Other: PMMTB (Precision Medicine Molecular Tumor Board)']}], 'interventions': [{'name': 'PMMTB (Precision Medicine Molecular Tumor Board)', 'type': 'OTHER', 'description': 'PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.', 'armGroupLabels': ['PMMTB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cancer Connect', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}, {'name': 'Mark Burkard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Cancer Connect', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '8006228922'}], 'overallOfficials': [{'name': 'Mark Burkard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}