Survivors of Childhood CancerNCT07884474
Feasibility and Acceptability of Remote Saliva Collection
An observational study of Survivors of Childhood Cancer and Acute Lymphoblastic Leukemia, Childhood, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Survivors of Childhood Cancer, Acute Lymphoblastic Leukemia, Childhood
- What is being tested?
- Salivary Cortisol Collection, Blood Biomarker Collection and Hair Cortisol Collection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2029
- Phase
- Observational
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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will include child and adolescent survivors of ALL, their siblings, and caregivers.
Who may be able to join
- 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:
- TOTAL Therapy study XVI for Newly Diagnosed Patients with ALL (TOTXVI) OR
- Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma (TOT17)
- The survivor is cancer-free.
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- 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.
Who cannot join
- 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.
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
Bria Gresham, PhD, 866-278-5833, referralinfo@stjude.org
Bria Gresham, PhD
About this study
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.
Read the detailed description
Childhood survivors of acute lymphoblastic leukemia (ALL) can experience long-term health problems after cancer treatment. Researchers believe that stress-related biological processes and social factors, such as neighborhood socioeconomic conditions, may influence long-term health outcomes. However, it is not known whether collecting multiple biological samples over several days is practical for survivors and their families.
This feasibility and acceptability study will enroll survivors of childhood ALL, their siblings, and caregivers. Participants may complete study activities through a combination of in-person and remote procedures or through a fully remote option.
Participants will complete an enrollment visit, a baseline visit conducted either in person or remotely, and a telehealth reminder visit. Survivors and siblings will provide saliva, blood, hair, and fingernail samples. Saliva samples will be collected at home five times per day over three days. Participants will also wear a WatchPAT sleep monitoring device and complete morning and evening diaries during the saliva collection period. Questionnaires will assess demographic information, sleep, emotional well-being, family relationships, health behaviors, and other factors that may influence cortisol measurements. Caregivers will complete questionnaires about household and demographic characteristics and provide feedback regarding study acceptability.
Blood samples will be used to measure markers of inflammation and hormone function. Saliva, hair, and fingernail samples will be used to evaluate cortisol, a biological marker related to stress and hypothalamic-pituitary-adrenal (HPA) axis functioning. The study will also explore associations between neighborhood socioeconomic status and biological measures of cortisol and inflammation. Findings from this feasibility study will be used to inform the design of future research investigating the effects of cancer treatment and social environments on long-term health outcomes among childhood ALL survivors.
- Being tested
- Salivary Cortisol Collection, Blood Biomarker Collection, Hair Cortisol Collection, Nail Cortisol Collection, WatchPAT Sleep Assessment
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary Cortisol CollectionDiagnostic test
Also called Saliva Sampling; Saliva 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 CollectionDiagnostic test
Also called Blood Collection; Blood Sampling; Venipuncture; RedDrop One Blood 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 CollectionDiagnostic test
Also called Hair Sample 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 CollectionDiagnostic test
Also called Fingernail Collection; Nail Sample Collection
Fingernail clippings from all ten fingernails are collected to measure nail cortisol levels.
WatchPAT Sleep AssessmentDiagnostic test
Also called WatchPAT 300; WatchPAT ONE; Wearable Sleep Monitor
FDA-approved wearable sleep assessment device used to measure sleep/wake times and sleep quality during the saliva collection period.
Morning and Evening DiariesBehavioural
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 MonitoringOther
Also called Aardex MEMS Caps; Medication Event Monitoring System Caps
Electronic caps used with saliva collection tubes to record date and time of each bottle opening, providing objective assessment of saliva collection adherence.
OnTimePoint ApplicationOther
Mobile/web-based application that provides saliva collection reminders and records sample collection timing and participant-reported wake times.
Survey and Questionnaire AssessmentOther
Collection of demographic, psychosocial, sleep, medication, socioeconomic, acceptability, and health-related survey data from survivors, siblings, and caregivers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Salivary Cortisol Collection; Diagnostic Test: Blood Biomarker Collection; Diagnostic Test: Hair Cortisol Collection; Diagnostic Test: Nail Cortisol Collection; Diagnostic Test: WatchPAT Sleep Assessment; Behavioral: Morning and Evening Diaries; Other: MEMS Cap Adherence Monitoring; Other: OnTimePoint Application; Other: Survey and Questionnaire Assessment | |
| Siblings of ALL Survivors | Biological or household siblings of enrolled ALL survivors, aged 8-18 years. Receives: Diagnostic Test: Salivary Cortisol Collection; Diagnostic Test: Blood Biomarker Collection; Diagnostic Test: Hair Cortisol Collection; Diagnostic Test: Nail Cortisol Collection; Diagnostic Test: WatchPAT Sleep Assessment; Behavioral: Morning and Evening Diaries; Other: MEMS Cap Adherence Monitoring; Other: OnTimePoint Application; Other: Survey and Questionnaire Assessment | |
| Caregivers | Primary caregivers residing full-time with enrolled survivors and siblings. Receives: Other: Survey and Questionnaire Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Feasibility
Proportion of participants approached that enroll in the study
Measured: Baseline through study completion, approximately 3 months after enrollment
Saliva Sampling Feasibility
Proportion of participants who complete the saliva sampling procedures will adhere to the timing of the saliva sampling
Measured: Baseline through study completion, approximately 3 months after enrollment
Blood Sampling Feasibility
Proportion of participants enrolled who complete the blood sample collection
Measured: Baseline through study completion, approximately 3 months after enrollment
Hair Sampling Feasibility
Proportion of participants enrolled that completed the hair sample collection
Measured: Baseline through study completion, approximately 3 months after enrollment
Fingernail Sampling Feasibility
Proportion of participants enrolled that completed the fingernail sample collection
Measured: Baseline through study completion, approximately 3 months after enrollment
Overall Study Procedure Feasibility
Proportion of participants enrolled that completed each study procedure
Measured: Baseline through study completion, approximately 3 months after enrollment
Secondary outcomes (20)
Saliva Sampling Acceptability-Acceptability Measure
A measure of saliva sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Measured: Post study, approximately 3 months after enrollment
Blood Sampling Acceptability-Acceptability Measure
A measure of blood sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Measured: Post study, approximately 3 months after enrollment
Hair Sampling Acceptability-Acceptability Measure
A measure of hair sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Measured: Post study, approximately 3 months after enrollment
Fingernail Sampling Acceptability-Acceptability Measure
A measure of fingernail sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Measured: Post study, approximately 3 months after enrollment
Overall Biospecimen Acceptability-Acceptability Measure
A measure of overall biospecimen acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Measured: Post study, approximately 3 months after enrollment
Overall Study Procedure Acceptability-Acceptability Measure
A measure of overall study acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of overall study acceptability.
Measured: Post study, approximately 3 months after enrollment
Neighborhood Socioeconomic Status (nSES)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with cortisol awakening response. Cortisol awakening response will be measured via the slope of four morning saliva samples (upon waking, +30 minutes, +45 minutes, +60 minutes) across three days, with values at each time point averaged across days.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Cortisol Diurnal Rhythm
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with cortisol diurnal rhythm. Cortisol diurnal rhythm will be measured via the slope of five daily saliva samples (upon waking, +30 minutes, +45 minutes, +60 minutes, bedtime) across three days, with values at each time point averaged across days.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Hair Cortisol Concentration
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with hair cortisol concentration. Hair cortisol concentration will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Nail Cortisol Concentration
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with nail cortisol concentration. Nail cortisol concentration will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and High-Sensitivity C-Reactive Protein (hs-CRP)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with high-sensitivity c-reactive protein (hs-CRP). Plasma hs-CRP will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interferon gamma (IFN-y)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interferon gamma (IFN-y). Plasma IFN-y will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 1 beta (IL-1β)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 1 beta (IL-1β). Plasma IL-1β will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 2 (IL-2)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 2 (IL-2). Plasma IL-2 will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 4 (IL-4)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 4 (IL-4). Plasma IL-4 will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 6 (IL-6)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 6 (IL-6). Plasma IL-6 will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 10 (IL-10)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 10 (IL-10). Plasma IL-10 will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 12 (IL-12p70)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 12 (IL-12p70). Plasma IL-12p70 will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 17A (IL-17A)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with interleukin 17A (IL-17A). Plasma IL-17A will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Tumor Necrosis Factor - alpha (TNF- α)
Determine whether neighborhood socioeconomic status (nSES), operationalizing using participants' address histories to estimate long-term neighborhood conditions, is associated with Tumor Necrosis Factor - alpha (TNF- α). Plasma (TNF- α) will be evaluated as a continuous measure.
Measured: Post study, approximately 6 months after accrual ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Childhood CancerStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bria Gresham, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884474
- Sponsor's protocol ID
- FARSC
- Other IDs
- U54CA302464, NCI-2026-06979
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No