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RecruitingNCT07884474Updated Oct 20, 2026

Feasibility and Acceptability of Remote Saliva Collection

An observational study in Survivors of Childhood Cancer and Acute Lymphoblastic Leukemia, Childhood, sponsored by St. Jude Children's Research Hospital. Recruiting at 1 site in United States. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by St. Jude Children's Research Hospital · Observational

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Survivors of Childhood Cancer
  • Acute Lymphoblastic Leukemia, Childhood
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 313 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 439 studies on the registry; 101 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.

Browse St. Jude Children's Research Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will include child and adolescent survivors of ALL, their siblings, and caregivers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    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.

    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.

    Other: Survey and Questionnaire Assessment

Interventions

  • Diagnostic testSalivary 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.

    Also known as: Saliva Sampling; Saliva Collection

  • Diagnostic testBlood 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.

    Also known as: Blood Collection; Blood Sampling; Venipuncture; RedDrop One Blood Collection

  • Diagnostic testHair 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.

    Also known as: Hair Sample Collection

  • Diagnostic testNail Cortisol Collection

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

    Also known as: Fingernail Collection; Nail Sample Collection

  • Diagnostic testWatchPAT Sleep Assessment

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

    Also known as: WatchPAT 300; WatchPAT ONE; Wearable Sleep Monitor

  • BehavioralMorning 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.

  • OtherMEMS 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.

    Also known as: Aardex MEMS Caps; Medication Event Monitoring System Caps

  • OtherOnTimePoint Application

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

  • OtherSurvey and Questionnaire Assessment

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

06

What researchers measure

Primary outcomes

  1. Enrollment Feasibility

    Proportion of participants approached that enroll in the study

    Time frame: Baseline through study completion, approximately 3 months after enrollment

  2. Saliva Sampling Feasibility

    Proportion of participants who complete the saliva sampling procedures will adhere to the timing of the saliva sampling

    Time frame: Baseline through study completion, approximately 3 months after enrollment

  3. Blood Sampling Feasibility

    Proportion of participants enrolled who complete the blood sample collection

    Time frame: Baseline through study completion, approximately 3 months after enrollment

  4. Hair Sampling Feasibility

    Proportion of participants enrolled that completed the hair sample collection

    Time frame: Baseline through study completion, approximately 3 months after enrollment

  5. Fingernail Sampling Feasibility

    Proportion of participants enrolled that completed the fingernail sample collection

    Time frame: Baseline through study completion, approximately 3 months after enrollment

  6. Overall Study Procedure Feasibility

    Proportion of participants enrolled that completed each study procedure

    Time frame: Baseline through study completion, approximately 3 months after enrollment

Secondary outcomes

  1. 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.

    Time frame: Post study, approximately 3 months after enrollment

  2. 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.

    Time frame: Post study, approximately 3 months after enrollment

  3. 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.

    Time frame: Post study, approximately 3 months after enrollment

  4. 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.

    Time frame: Post study, approximately 3 months after enrollment

  5. 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.

    Time frame: Post study, approximately 3 months after enrollment

  6. 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.

    Time frame: Post study, approximately 3 months after enrollment

  7. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  8. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  9. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  10. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  11. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  12. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  13. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  14. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  15. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  16. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  17. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  18. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  19. 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.

    Time frame: Post study, approximately 6 months after accrual ends

  20. 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.

    Time frame: Post study, approximately 6 months after accrual ends

07

Study locations

1 of 1 sites recruiting
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    Recruiting
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.

Of 107 non-industry observational studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 176. This study's planned 18 months is below that.

Counting every sponsor, half of 123 studies reached it within 64 months; a quarter within 38 and three quarters within 159.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2026
First posted
Oct 20, 2026
StartEst.
Oct 2026
Primary completionEst.
Apr 2028
CompletionEst.
Oct 2029
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07884474
Lead sponsor
St. Jude Children's Research Hospital
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Oct 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Bria Gresham, PhD
Contact
referralinfo@stjude.org
866-278-5833
Bria Gresham, PhD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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