Genetic PredispositionOnTRACNCT07456904
Outcomes of Health Care Transition for AYA With a Cancer Predisposition
An observational study of Genetic Predisposition, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Predisposition
- What is being tested?
- Readiness Assessment, Transition Outcomes Survey A and Transition Outcomes Survey B
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2026to Nov 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study
Who may be able to join
- 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.
Who cannot join
- Participants who are not their own legal medical decision-maker.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Melissa R Perrino, MD, 888-226-4343, referralinfo@stjude.org
About this study
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
Read more
- 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.
Read the 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.
- Conditions
- Genetic Predisposition
- Being tested
- Readiness Assessment, Transition Outcomes Survey A, Transition Outcomes Survey B
- Keywords
- Genetic cancer risk, Cancer predisposition, Health care transition, Adolescent and young adult oncology
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Readiness AssessmentBehavioural
Electronic assessment administered 1 month post-graduation to evaluate transition preparedness.
Transition Outcomes Survey ABehavioural
Administered at 1 and 3 years post-graduation to assess health care engagement and psychosocial outcomes.
Transition Outcomes Survey BBehavioural
Administered at 5 and 8 years post-graduation to assess long-term outcomes and cancer surveillance adherence.
| Study group | Role | What they receive |
|---|---|---|
| Transition Cohort | AYAs with CPS who have graduated from SJCRH and are followed longitudinally through surveys and assessments to evaluate health care transition outcomes. Receives: Behavioral: Readiness Assessment; Behavioral: Transition Outcomes Survey A; Behavioral: Transition Outcomes Survey B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Evaluated 3 years after consent from the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start16 Jun 2026
- Primary completionNov 2034 (estimated)
- Study completionNov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa R Perrino, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456904
- Sponsor's protocol ID
- OnTRAC
- Acronym
- OnTRAC
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Health Care Transition for AYA With a Cancer Predisposition
- ClinicalTrials.gov ID
- NCT07456904
- Acronym / sponsor ID
- OnTRAC / OnTRAC
- Conditions
- Genetic Predisposition
- Keywords
- Genetic cancer risk, Cancer predisposition, Health care transition, Adolescent and young adult oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Nov 2034 (estimated)
- Study completion
- Nov 2037 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transition Cohort | – | Behavioral: Readiness Assessment, Behavioral: Transition Outcomes Survey A, Behavioral: Transition Outcomes Survey BAYAs with CPS who have graduated from SJCRH and are followed longitudinally through surveys and assessments to evaluate health care transition outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are not their own legal medical decision-maker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Readiness AssessmentElectronic assessment administered 1 month post-graduation to evaluate transition preparedness. | Behavioural | Transition Cohort |
| Transition Outcomes Survey AAdministered at 1 and 3 years post-graduation to assess health care engagement and psychosocial outcomes. | Behavioural | Transition Cohort |
| Transition Outcomes Survey BAdministered at 5 and 8 years post-graduation to assess long-term outcomes and cancer surveillance adherence. | Behavioural | Transition Cohort |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa R Perrino, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa R Perrino, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of Adult Health Care (time frame: Evaluated 1 year after consent from the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.