Metabolomics of Cancers of the Upper Aerodigestive Tract
报名条件(概要)
- 年龄:18 Years – 不限
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
France
药品与企业信息
blood samples collection at screening and between the 3rd and 6th month after the end of treatment.
Urine samples collection at screening and between the 3rd and 6th month after the end of treatment.
研发企业
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。
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)
Metabolomics, thanks to advances in mass spectrometry, allows for the analysis of cellular metabolites to better understand biological processes. In oncology, it provides a global view of metabolic alterations in tumors and enables the classification of cancers based on various medical parameters using advanced statistical methods (machine learning). Its low cost and speed make it a promising approach in personalized medicine. Cancers of the upper aerodigestive tract (UADT), the fifth most common cancer in France, are often diagnosed late, reducing survival chances (35-50% at five years). Identifying a specific metabolomic signature for these cancers could facilitate early detection, assess treatment response, and rapidly detect recurrences. Additionally, HPV-induced tumors may exhibit a distinct metabolic profile compared to those caused by tobacco and alcohol. Currently, no published studies have explored this topic for UADT cancers, highlighting the need for such research. The aim of this study is to identify a metabolomic signature associated with the presence of UADT cancer at initial diagnosis and during post-therapeutic follow-up (three months after treatment completion). Hypothesis is that a specific metabolomic signature will be observed in the biological samples of patients diagnosed with UADT cancer, that the type of observed signature could be correlated with tumor site, stage, HPV status, and prognosis, and that the persistence or disappearance of this metabolomic signature three months after treatment may be associated with the risk of recurrence. The search for this potential metabolomic signature will be conducted using tumor biopsies, plasma, and urine samples at the initial diagnostic phase and plasma and urine samples at three and six months post-treatment follow-up. Ultimately, the benefits of this study lie in improving early diagnosis, treatment (adjusting treatment based on the prognostic value of specific metabolomic signatures), and follow-up (early detection of recurrences, adapting monitoring to each patient's individual risk) of UADT cancers. As the study is based on biological samples collected as part of standard patient care (with no additional biological tests or procedures performed specifically for research), no research-related risk is expected for the patient. This is a prospective, single-center study involving patients with histologically confirmed, untreated squamous cell carcinoma of the UADT (oral cavity, oropharynx, larynx, and hypopharynx) who will receive curative treatment at the Antoine Lacassagne Center. The search for a potential metabolomic signature will be conducted using biological and tumor samples collected as part of standard patient care, without requiring additional tests or procedures. The primary objective of the study is to identify a metabolomic signature in patients with UADT cancer. The secondary objectives of the study are: * To investigate the correlation between a metabolomic signature and tumor characteristics. * To examine the relationship between a metabolomic signature at three to six months post-treatment and oncological status at three to six months and one year post-treatment in patients with UADT cancer.
适应症
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 →研究中心联系方式
- Centre Antoine LacassagneNice,France
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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: Metabolomics of Cancers of the Upper Aerodigestive Tract ClinicalTrials.gov Identifier: NCT07377084 Sponsor: Centre Antoine Lacassagne Investigational product: Blood samples for the analysis of sildenafil in plasma, urine samples 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:Metabolomics of Cancers of the Upper Aerodigestive Tract 试验编号:NCT07377084 申办方:Centre Antoine Lacassagne 研究药物:Blood samples for the analysis of sildenafil in plasma、urine samples 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)
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?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 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)。