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Feasibility and Acceptability of Remote Saliva Collection

2 ноября 2026 г. обновлено: St. Jude Children's Research Hospital

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

100

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Bria Gresham, PhD
  • Номер телефона: 866-278-5833
  • Электронная почта: referralinfo@stjude.org

Места учебы

  • Соединенные Штаты
    • Tennessee
      • Memphis, Tennessee, Соединенные Штаты, 38105
        • Рекрутинг
        • St. Jude Children's Research Hospital
        • Контакт:
          • Bria Gresham, PhD
          • Номер телефона: 866-278-5833
          • Электронная почта: referralinfo@stjude.org
        • Главный следователь:
          • Bria Gresham, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 8 лет до 18 лет (Ребенок, Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Наблюдательные модели: COHORT
  • Временные перспективы: PROSPECTIVE

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
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.
Диагностический тест: 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.

Другие имена:
  • Saliva Sampling; Saliva Collection
Диагностический тест: 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.

Другие имена:
  • Blood Collection; Blood Sampling; Venipuncture; RedDrop One Blood Collection
Диагностический тест: 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.

Другие имена:
  • Hair Sample Collection
Диагностический тест: Nail Cortisol Collection

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

Другие имена:
  • Fingernail Collection; Nail Sample Collection
Диагностический тест: WatchPAT Sleep Assessment

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

Другие имена:
  • WatchPAT 300; WatchPAT ONE; Wearable Sleep Monitor
Поведенческий: 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.

Другой: 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.

Другие имена:
  • Aardex MEMS Caps; Medication Event Monitoring System Caps
Другой: OnTimePoint Application

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

Другой: Survey and Questionnaire Assessment

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

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

Другие имена:
  • Saliva Sampling; Saliva Collection
Диагностический тест: 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.

Другие имена:
  • Blood Collection; Blood Sampling; Venipuncture; RedDrop One Blood Collection
Диагностический тест: 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.

Другие имена:
  • Hair Sample Collection
Диагностический тест: Nail Cortisol Collection

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

Другие имена:
  • Fingernail Collection; Nail Sample Collection
Диагностический тест: WatchPAT Sleep Assessment

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

Другие имена:
  • WatchPAT 300; WatchPAT ONE; Wearable Sleep Monitor
Поведенческий: 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.

Другой: 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.

Другие имена:
  • Aardex MEMS Caps; Medication Event Monitoring System Caps
Другой: OnTimePoint Application

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

Другой: Survey and Questionnaire Assessment

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

Primary caregivers residing full-time with enrolled survivors and siblings.
Другой: Survey and Questionnaire Assessment

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Enrollment Feasibility
Временное ограничение: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants approached that enroll in the study
Baseline through study completion, approximately 3 months after enrollment
Saliva Sampling Feasibility
Временное ограничение: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants who complete the saliva sampling procedures will adhere to the timing of the saliva sampling
Baseline through study completion, approximately 3 months after enrollment
Blood Sampling Feasibility
Временное ограничение: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled who complete the blood sample collection
Baseline through study completion, approximately 3 months after enrollment
Hair Sampling Feasibility
Временное ограничение: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled that completed the hair sample collection
Baseline through study completion, approximately 3 months after enrollment
Fingernail Sampling Feasibility
Временное ограничение: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled that completed the fingernail sample collection
Baseline through study completion, approximately 3 months after enrollment
Overall Study Procedure Feasibility
Временное ограничение: Baseline through study completion, approximately 3 months after enrollment

Proportion of participants enrolled that completed each study procedure
Baseline through study completion, approximately 3 months after enrollment

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Saliva Sampling Acceptability-Acceptability Measure
Временное ограничение: Post study, approximately 3 months after enrollment

A measure of saliva sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Blood Sampling Acceptability-Acceptability Measure
Временное ограничение: Post study, approximately 3 months after enrollment

A measure of blood sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Hair Sampling Acceptability-Acceptability Measure
Временное ограничение: Post study, approximately 3 months after enrollment

A measure of hair sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Fingernail Sampling Acceptability-Acceptability Measure
Временное ограничение: Post study, approximately 3 months after enrollment

A measure of fingernail sampling acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Overall Biospecimen Acceptability-Acceptability Measure
Временное ограничение: Post study, approximately 3 months after enrollment

A measure of overall biospecimen acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of intervention acceptability.
Post study, approximately 3 months after enrollment
Overall Study Procedure Acceptability-Acceptability Measure
Временное ограничение: Post study, approximately 3 months after enrollment

A measure of overall study acceptability. Scores of ≥4 on a 5-point Likert scale will be indicative of overall study acceptability.
Post study, approximately 3 months after enrollment
Neighborhood Socioeconomic Status (nSES)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Cortisol Diurnal Rhythm
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Hair Cortisol Concentration
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Nail Cortisol Concentration
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and High-Sensitivity C-Reactive Protein (hs-CRP)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interferon gamma (IFN-y)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 1 beta (IL-1β)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 2 (IL-2)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 4 (IL-4)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 6 (IL-6)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 10 (IL-10)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 12 (IL-12p70)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Interleukin 17A (IL-17A)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends
Neighborhood Socioeconomic Status (nSES) and Tumor Necrosis Factor - alpha (TNF- α)
Временное ограничение: Post study, approximately 6 months after accrual ends

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.
Post study, approximately 6 months after accrual ends

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

St. Jude Children's Research Hospital

Соавторы

National Cancer Institute (NCI)

Следователи

  • Главный следователь: Bria Gresham, PhD, St. Jude Children's Research Hospital

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 декабря 2026 г.

Первичное завершение (Оцененный)

1 апреля 2028 г.

Завершение исследования (Оцененный)

1 октября 2029 г.

Даты регистрации исследования

Первый отправленный

25 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

13 октября 2026 г.

Первый опубликованный (Действительный)

20 октября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • FARSC
  • U54CA302464 (Грант/контракт NIH США)
  • NCI-2026-06979 (Другой идентификатор: NCI Clinical Trial Registration Program)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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