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NCT07884474

Feasibility and Acceptability of Remote Saliva Collection

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-12

Completion Date

2029-10

Last Updated

2026-11-03

Healthy Volunteers

Yes

Conditions

Survivors of Childhood Cancer Acute Lymphoblastic Leukemia, Childhood

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Nail Cortisol Collection

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

DIAGNOSTIC_TEST

WatchPAT Sleep Assessment

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

BEHAVIORAL

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.

OTHER

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.

OTHER

OnTimePoint Application

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

OTHER

Survey and Questionnaire Assessment

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

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.

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Clinical Research Directory

Feasibility and Acceptability of Remote Saliva Collection

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)