Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT06482957
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2024-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}, {'id': 'D014015', 'term': 'Tissue Banks'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'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': 'D018070', 'term': 'Biological Specimen Banks'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of disease on adverse oncologic outcomes', 'timeFrame': 'Approximately six years', 'description': 'Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)'}, {'measure': 'Impact of treatment on adverse oncologic outcomes', 'timeFrame': 'Approximately six years', 'description': 'Medical record review of Common Terminology Criteria for Adverse Events (CTCAEs)'}, {'measure': 'Impact of sociodemographic contributors on adverse oncologic outcomes', 'timeFrame': 'Approximately six years', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Scores'}, {'measure': 'Impact of lifestyle contributors on adverse oncologic outcomes', 'timeFrame': 'Approximately six years', 'description': 'Patient-reported outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.', 'detailedDescription': '* To evaluate the incidence and prevalence and the impact of disease, treatment, sociodemographic and lifestyle contributors on adverse oncologic outcomes (lack of response, recurrence) and non- oncologic outcomes (physical and psychosocial function, financial toxicity, short and long-term organ toxicity) and mortality in the cohort.\n* To evaluate the role of drug metabolism and DNA repair genes via functional polymorphisms, known toxicity associated polymorphisms and genetically predicted gene expression levels, as well as polygenic risk scores, on treatment efficacy, cancer therapy-induced normal tissue toxicity and mortality.\n* To identify genomic drivers of sarcoma and to use this information to develop personalized liquid biopsy assays for monitoring treatment response, recurrence, and minimal residual disease (MRD) and mortality.\n* Evaluate family functioning, psychosocial wellbeing, and financial toxicity.\n\nOUTLINE: This is an observational study.\n\nPatients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at any age with a history of sarcoma, with or without evidence of a persistent disease and parent/caregiver of pediatric patients and siblings of patients 8 years or older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients at any age with a history of sarcoma, with or without evidence of a persistent disease\n\n• For pediatric patients\n\n* Parent/primary caregiver of patient\n* Sibling of patient aged 8 years or older'}, 'identificationModule': {'nctId': 'NCT06482957', 'acronym': 'CAUSAL', 'briefTitle': 'Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan', 'orgStudyIdInfo': {'id': 'VICCPED2222'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00569', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}, {'id': '1UG3CA260318-01', 'link': 'https://reporter.nih.gov/quickSearch/1UG3CA260318-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients monitor physical activity, sedentary behavior, heart rate and sleep wearing a FitBit device, undergo blood urine, stool and/or saliva sample collection, complete surveys and have medical records reviewed throughout study.', 'interventionNames': ['Other: Surveys', 'Other: Blood Collection', 'Other: Saliva Collection', 'Other: Urine Collection', 'Other: Stool Collection', 'Other: Tissue collection', 'Other: Physical Activity Monitoring']}], 'interventions': [{'name': 'Surveys', 'type': 'OTHER', 'description': 'Complete surveys', 'armGroupLabels': ['Observational']}, {'name': 'Blood Collection', 'type': 'OTHER', 'description': 'Undergo blood collection', 'armGroupLabels': ['Observational']}, {'name': 'Saliva Collection', 'type': 'OTHER', 'description': 'Undergo salvia collection', 'armGroupLabels': ['Observational']}, {'name': 'Urine Collection', 'type': 'OTHER', 'description': 'Undergo urine collection', 'armGroupLabels': ['Observational']}, {'name': 'Stool Collection', 'type': 'OTHER', 'description': 'Undergo stool collection', 'armGroupLabels': ['Observational']}, {'name': 'Tissue collection', 'type': 'OTHER', 'description': 'Undergo tissue collection', 'armGroupLabels': ['Observational']}, {'name': 'Physical Activity Monitoring', 'type': 'OTHER', 'description': 'FitBit will be worn to track physical activity', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Service for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Debra Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}], 'overallOfficials': [{'name': 'Debra Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University/Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics (Pediatric Hematology and Oncology)', 'investigatorFullName': 'Debra Friedman', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}