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:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Outcomes of Health Care Transition for AYA With a Cancer Predisposition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OnTRAC
Brief Summary:
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.
Primary Objectives
* 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.
* 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.
Exploratory Objectives:
* 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).
* To examine clinical correlates of establishing care with adult providers and initiating CPS-specific cancer surveillance post-graduation from SJCRH.
* 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).
* To identify barriers and facilitators AYAs face when establishing and maintaining adult health care and pursuing CPS-specific cancer surveillance.
Primary Objectives
* 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.
* 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.
Exploratory Objectives:
* 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).
* To examine clinical correlates of establishing care with adult providers and initiating CPS-specific cancer surveillance post-graduation from SJCRH.
* 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).
* To identify barriers and facilitators AYAs face when establishing and maintaining adult health care and pursuing CPS-specific cancer surveillance.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: