Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:22 AM
Study NCT ID:
NCT07456904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Health Care Transition for AYA With a Cancer Predisposition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2037-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishment of Adult Health Care', 'timeFrame': 'Evaluated 1 year after consent from the study.', 'description': 'Proportion of Young Adults with Cancer Predisposition Syndromes Who Have an Identified Adult Medical Provider Managing Cancer Surveillance One Year Post-Pediatric Care Transition'}, {'measure': 'Maintenance of Adult Health Care', 'timeFrame': 'Evaluated 3 years after consent from the study.', 'description': 'Proportion of Young Adults with Cancer Predisposition Syndromes Who Maintain an Identified Adult Medical Provider for Cancer Surveillance Three Years Post-Pediatric Care Transition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetic cancer risk', 'Cancer predisposition', 'Health care transition', 'Adolescent and young adult oncology'], 'conditions': ['Genetic Predisposition']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': "This observational study evaluates whether adolescents and young adults (AYAs) with a cancer predisposition syndrome (CPS) establish and maintain adult health care and continue CPS-specific cancer surveillance after graduating from pediatric care at St. Jude Children's Research Hospital (SJCRH). Participants will complete a Readiness Assessment and periodic surveys over 8 years post-graduation.\n\nPrimary Objectives\n\n* To evaluate whether adolescents and young adults (AYAs) with a cancer predisposition syndrome (CPS) report they have established care with adult health care providers and pursue CPS-specific cancer surveillance within 1-year post-graduation from SJCRH.\n* To evaluate whether AYAs with CPS report they maintain care with adult health care providers and continue CPS-specific cancer surveillance 3 years post-graduation from SJCRH.\n\nExploratory Objectives:\n\n* To evaluate whether AYAs with CPS report they continue to maintain care with adult health care providers and complete CPS-specific cancer surveillance longitudinally 5 years and 8 years post-graduation from St. Jude Children's Research Hospital (SJCRH).\n* To examine clinical correlates of establishing care with adult providers and initiating CPS-specific cancer surveillance post-graduation from SJCRH.\n* To identify the tumors diagnosed in AYAs with CPS after they graduate from SJCRH and determine how these tumors were identified (i.e., through specific surveillance tests or based on symptoms).\n* To identify barriers and facilitators AYAs face when establishing and maintaining adult health care and pursuing CPS-specific cancer surveillance.", 'detailedDescription': 'The OnTRAC study investigates the outcomes of AYAs with CPS following their transition from pediatric to adult health care. The study aims to assess whether participants establish care with adult providers and adhere to recommended cancer surveillance protocols. Participants will complete a Readiness Assessment one month post-graduation and electronic Transition Outcomes Surveys at 1, 3, 5, and 8 years. These surveys will evaluate health care engagement, cancer screening adherence, barriers and facilitators to care, and psychosocial experiences. The study will also explore clinical and demographic correlates of successful transition and surveillance adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants who meet eligibility criteria and consent to enrollment on the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants are ≥18 years of age\n* Participants with a molecular or clinical diagnosis of a Cancer Predisposition Syndrome (CPS) who are graduating or have graduated from SJCRH.\n* Participants who were a patient of the SJCRH Cancer Predisposition Clinic for at least 3 years before graduating from SJCRH\n* Participants who require cancer/tumor surveillance within 1 year after graduation from SJCRH. Required cancer/tumor surveillance in adulthood is defined as having a CPS with expert guidelines recommending cancer/tumor surveillance in adulthood\n* Participants fluent in English.\n\nExclusion Criteria:\n\n* Participants who are not their own legal medical decision-maker.'}, 'identificationModule': {'nctId': 'NCT07456904', 'acronym': 'OnTRAC', 'briefTitle': 'Outcomes of Health Care Transition for AYA With a Cancer Predisposition', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Outcomes of Health Care Transition for AYA With a Cancer Predisposition', 'orgStudyIdInfo': {'id': 'OnTRAC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transition Cohort', 'description': 'AYAs with CPS who have graduated from SJCRH and are followed longitudinally through surveys and assessments to evaluate health care transition outcomes.', 'interventionNames': ['Behavioral: Readiness Assessment', 'Behavioral: Transition Outcomes Survey A', 'Behavioral: Transition Outcomes Survey B']}], 'interventions': [{'name': 'Readiness Assessment', 'type': 'BEHAVIORAL', 'description': 'Electronic assessment administered 1 month post-graduation to evaluate transition preparedness.', 'armGroupLabels': ['Transition Cohort']}, {'name': 'Transition Outcomes Survey A', 'type': 'BEHAVIORAL', 'description': 'Administered at 1 and 3 years post-graduation to assess health care engagement and psychosocial outcomes.', 'armGroupLabels': ['Transition Cohort']}, {'name': 'Transition Outcomes Survey B', 'type': 'BEHAVIORAL', 'description': 'Administered at 5 and 8 years post-graduation to assess long-term outcomes and cancer surveillance adherence.', 'armGroupLabels': ['Transition Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Melissa R Perrino, MD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'Melissa R Perrino, MD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}], 'overallOfficials': [{'name': 'Melissa R Perrino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}