Outcomes of Health Care Transition for AYA With a Cancer... | NCT07456904

Studies
Outcomes of Health Care Transition for AYA With a Cancer Predisposition

NCT07456904

Sponsor

St. Jude Children's Research Hospital

Status

Recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

56Estimated

Phase

Not provided

Conditions

Genetic Predisposition

Interventions

Readiness Assessment
Transition Outcomes Survey A
Transition Outcomes Survey B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2026Actual

Primary Completion Date

Nov 2034Estimated

Completion Date

Nov 2037Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 3, 2026

First Posted Date

Mar 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transition Cohort		AYAs with CPS who have graduated from SJCRH and are followed longitudinally through surveys and assessments to evaluate health care transition outcomes.	Behavioral: Readiness Assessment Behavioral: Transition Outcomes Survey A Behavioral: Transition Outcomes Survey B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Readiness Assessment	Behavioral	Electronic assessment administered 1 month post-graduation to evaluate transition preparedness.	Transition Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Establishment of Adult Health Care	Proportion of Young Adults with Cancer Predisposition Syndromes Who Have an Identified Adult Medical Provider Managing Cancer Surveillance One Year Post-Pediatric Care Transition	Evaluated 1 year after consent from the study.
Maintenance of Adult Health Care	Proportion of Young Adults with Cancer Predisposition Syndromes Who Maintain an Identified Adult Medical Provider for Cancer Surveillance Three Years Post-Pediatric Care Transition	Evaluated 3 years after consent from the study.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants are ≥18 years of age
Participants with a molecular or clinical diagnosis of a Cancer Predisposition Syndrome (CPS) who are graduating or have graduated from SJCRH.
Participants who were a patient of the SJCRH Cancer Predisposition Clinic for at least 3 years before graduating from SJCRH
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
Participants fluent in English.

Exclusion Criteria:

Participants who are not their own legal medical decision-maker.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Melissa R Perrino, MD	Contact	888-226-4343		referralinfo@stjude.org

Overall Officials

Name	Affiliation	Role
Melissa R Perrino, MD	St. Jude Children's Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Jude Children's Research Hospital	Recruiting	Memphis	Tennessee	38105	United States

References Module

Citations

Not provided

Label	URL
St. Jude Children's Research Hospital	View source
Clinical Trials Open at St. Jude	View source

ID	Term
D004198	Disease Susceptibility
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms