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正在招募不适用编号 NCT07884474

Feasibility and Acceptability of Remote Saliva Collection

报名条件（概要）

  • 年龄：8 Years – 18 Years
  • 性别：不限
  • 健康志愿者：接受

完整入排标准请以官方页面为准。

开展国家/地区

United States

药品与企业信息

Salivary Cortisol Collection诊断检测

其他名称：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 Collection诊断检测

其他名称：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 Collection诊断检测

其他名称：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 Collection诊断检测

其他名称：Fingernail Collection; Nail Sample Collection

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

WatchPAT Sleep Assessment诊断检测

其他名称：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 Diaries行为干预

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其他

其他名称：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 Application其他

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

研发企业

St. Jude Children's Research Hospital研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • National Cancer Institute (NCI)美国国立卫生研究院

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

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.

适应症

Survivors of Childhood CancerAcute Lymphoblastic Leukemia, Childhood

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人（申办方／研究总部）

研究中心联系方式

问自己是否符合条件、如何预筛

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Feasibility and Acceptability of Remote Saliva Collection
ClinicalTrials.gov Identifier: NCT07884474
Sponsor: St. Jude Children's Research Hospital
Investigational product: Salivary Cortisol Collection, Blood Biomarker Collection, Hair Cortisol Collection, Nail Cortisol Collection, WatchPAT Sleep Assessment

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：Feasibility and Acceptability of Remote Saliva Collection
试验编号：NCT07884474
申办方：St. Jude Children's Research Hospital
研究药物：Salivary Cortisol Collection、Blood Biomarker Collection、Hair Cortisol Collection、Nail Cortisol Collection、WatchPAT Sleep Assessment

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 referralinfo@stjude.org

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面