Outcomes of Health Care Transition for AYA With a Cancer Predisposition (OnTRAC)

June 2, 2026 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Electronic assessment administered 1 month post-graduation to evaluate transition preparedness.
Behavioral: Transition Outcomes Survey A
Administered at 1 and 3 years post-graduation to assess health care engagement and psychosocial outcomes.
Behavioral: Transition Outcomes Survey B
Administered at 5 and 8 years post-graduation to assess long-term outcomes and cancer surveillance adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment of Adult Health Care
Time Frame: Evaluated 1 year after consent from the study.
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
Time Frame: Evaluated 3 years after consent from the study.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Melissa R Perrino, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 1, 2034

Study Completion (Estimated)

November 1, 2037

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OnTRAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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