Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07884474

Conditions

Survivors of Childhood Cancer

Acute Lymphoblastic Leukemia, Childhood

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Accepted

Interventions

Salivary Cortisol Collection

Blood Biomarker Collection

Hair Cortisol Collection

Nail Cortisol Collection

WatchPAT Sleep Assessment

Study Details

Brief summary:

The purpose of this study is to evaluate the practicality and acceptability of collecting biological samples and health information from childhood survivors of acute lymphoblastic leukemia (ALL) and their siblings. Participants will provide saliva, blood, hair, and fingernail samples, complete questionnaires, and participate in sleep monitoring. The information collected will help researchers understand how cancer treatment and neighborhood conditions may affect stress hormones, inflammation, and long-term health.

Primary Objective

\- To evaluate the feasibility of collecting multiple biological specimens, surveys, and sleep assessment among child and adolescent survivors of ALL and their siblings.

Conditions

Survivors of Childhood Cancer

Acute Lymphoblastic Leukemia, Childhood

Study ID

NCT07884474

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

SURVIVORS

  • The survivor is a childhood survivor of Acute Lymphocytic Leukemia (ALL).
  • The survivor was treated on one of the following St. Jude Total Therapy Studies:

1. TOTAL Therapy study XVI for Newly Diagnosed Patients with ALL (TOTXVI) OR
2. Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma (TOT17)
  • The survivor is cancer-free.
  • The survivor is at least 5 years out from the ALL diagnosis.
  • The survivor is at least 2 years out from completion of treatment.
  • The survivor did not receive cranial therapy as part of ALL therapy.
  • The survivor is aged ≥8 to 18 years old at the time of enrollment.
  • The survivor has completed their After Completion of Therapy (ACT) clinic consultation.
  • The survivor is able to speak and read English.
  • The survivor has internet access.

SIBLINGS

  • The sibling has a brother or sister who is an ALL survivor participating in this study.
  • The sibling is aged ≥8 to18 years old at the time of enrollment.
  • The sibling is able to speak and read English.
  • The sibling has internet access.

CAREGIVERS

  • The caregiver provides primary care or support to an ALL survivor that is in this study.
  • The caregiver resides in the home full-time with enrolled survivor and sibling.
  • The caregiver is able to speak and read English.
  • The caregiver has internet access.
  • The caregiver is willing and able to assist with at home biospecimen collection.

Exclusion Criteria:

SURVIVORS and SIBLINGS

  • Survivor and/or sibling has a diagnosis of Down's Syndrome.
  • Survivor and/or sibling has a diagnosis of autism spectrum disorder.
  • Survivor and/or sibling has a diagnosis of another pervasive developmental disorder not listed above.
  • Survivor and/or sibling has a history of prolonged treatment with steroid medications or systemic glucocorticoids for reasons other than ALL.
  • Survivor and/or sibling resides outside of the United States.
  • Inability or unwillingness of survivor and/or sibling and/or legal guardian/representative to give written informed consent.

CAREGIVERS Note: There are no exclusion criteria for caregivers.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Childhood ALL Survivors

Childhood survivors of acute lymphoblastic leukemia treated on St. Jude Total Therapy XVI or Total Therapy 17 protocols who meet survivorship and age eligibility requirements.

Siblings of ALL Survivors

Biological or household siblings of enrolled ALL survivors, aged 8-18 years.

Caregivers

Primary caregivers residing full-time with enrolled survivors and siblings.

Interventions

Salivary Cortisol Collection

Participants collect five saliva samples per day on three days within a 14-day period (wake, +30 min, +45 min, +60 min, bedtime) to assess diurnal cortisol rhythm and cortisol awakening response.

Blood Biomarker Collection

Collection of blood samples to measure high-sensitivity C-reactive protein, pro-inflammatory cytokines, dehydroepiandrosterone, and luteinizing hormone. Hybrid participants undergo venipuncture (\~3 mL blood). Remote participants use the FDA-approved RedDrop One capillary blood collection device.

Hair Cortisol Collection

Collection of a small hair sample from the posterior vertex of the scalp to measure long-term cortisol exposure. Hair is cut close to the scalp and stored for laboratory analysis.

Nail Cortisol Collection

Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.

WatchPAT Sleep Assessment

FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.

Morning and Evening Diaries

Participants complete brief morning and evening diaries to record sleep, caffeine intake, medication use, symptoms, stress, affect, daily events, and other factors that may influence cortisol measurements.

MEMS Cap Adherence Monitoring

Electronic caps used with saliva collection tubes to record date and time of each bottle opening, providing objective assessment of saliva collection adherence.

OnTimePoint Application

Mobile/web-based application that provides saliva collection reminders and records sample collection timing and participant-reported wake times.

Survey and Questionnaire Assessment

Collection of demographic, psychosocial, sleep, medication, socioeconomic, acceptability, and health-related survey data from survivors, siblings, and caregivers.

Primary outcome measure

  • Enrollment Feasibility [ Time Frame: Baseline through study completion, approximately 3 months after enrollment ]
  • Saliva Sampling Feasibility [ Time Frame: Baseline through study completion, approximately 3 months after enrollment ]
  • Blood Sampling Feasibility [ Time Frame: Baseline through study completion, approximately 3 months after enrollment ]
  • Hair Sampling Feasibility [ Time Frame: Baseline through study completion, approximately 3 months after enrollment ]
  • Fingernail Sampling Feasibility [ Time Frame: Baseline through study completion, approximately 3 months after enrollment ]
  • Overall Study Procedure Feasibility [ Time Frame: Baseline through study completion, approximately 3 months after enrollment ]

Central Contacts and Locations

Central contacts

Bria Gresham, PhD

866-278-5833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Bria Gresham, PhD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Bria Gresham, PhD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.