一项关于早发性胃肠道癌症的前瞻性观察研究：从肿瘤特征到患者生活习惯 (YOGICO)
关于早发性胃肠道癌症的前瞻性观察研究：从肿瘤特征到患者生活习惯——YOGICO研究
The YOGICO study aims to characterize the distinctive features of EoGI cancer through a holistic approach that integrates clinical and demographic data, tumor biological characteristics, and patient lifestyle habits
研究概览
地位
条件
详细说明
This is an observational, prospective multicenter study to characterize newly diagnosed EoGI cancer patients from a holistic approach, covering aspects from tumor features to patient lifestyle habits. Since this is a prospective observational study, participation does not alter any cancer treatments that patients will undergo after their cancer diagnosis, as per best clinical practice at each participating center. The number of patients included in the study will range from 150 to 200, enrolled in national centers located in northern Italy, as well as in diverse hospital settings (e.g., small vs. large hospitals).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Ilaria Bernardini, MD
- 电话号码：+39 059659294
- 邮箱：i.bernardini@ausl.mo.it
学习地点
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BO
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Bologna、BO、意大利
- 尚未招聘
- Oncologia, Ospedale Sant'Orsola
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接触：
- Karim Rihawi, MD
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FC
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Meldola、FC、意大利
- 主动，不招人
- Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
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MO
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Carpi、MO、意大利
- 招聘中
- Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
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接触：
- Claudia Mucciarini, MD
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Modena、MO、意大利
- 主动，不招人
- Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
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Sassuolo、MO、意大利
- 招聘中
- Oncologia Area Sud Ausl Modena
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接触：
- Teresa Zielli, MD
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-
Minnesota
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Mantua、Minnesota、意大利
- 主动，不招人
- Oncologia Ospedale Carlo Poma di Mantova
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-
PC
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Piacenza、PC、意大利
- 主动，不招人
- Oncologia Medica, AUSL Piacenza
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-
PR
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Parma、PR、意大利
- 招聘中
- Oncologia, Azienda Ospedaliero Universitaria di Parma
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接触：
- Annalisa Gilli, MD
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RE
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Reggio Emilia、RE、意大利
- 招聘中
- Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
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接触：
- Francesco Caputo, MD
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RN
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Rimini、RN、意大利
- 招聘中
- Oncologia, Ospedale di Rimini
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接触：
- Francesca Fabbri, MD
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VA
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Varese、VA、意大利
- 尚未招聘
- Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
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接触：
- Michele Ghidini, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients will be selected and recruited during routine medical appointments by specialized medical oncologists at the participating cancer center. Patients will be enrolled consecutively based on inclusion and exclusion criteria
描述
Inclusion Criteria:
- Provide a signed and dated informed consent form (ICF)
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 18-49 years old at time of EoGI cancer diagnosis
- Patients with newly diagnosed early-onset gastrointestinal cancer histologically confirmed: colorectal, gastroesophageal and pancreatic tumor site, regardless of histological type
- Any disease stage, performance status, and type of treatment, including experimental therapies and supportive care
- Previous or concomitant malignancies are allowed provided they do not involve the gastrointestinal tract
Exclusion Criteria:
- Cognitive, linguistic, or physical barriers that prevent a detailed reconstruction of the patient's personal medical history including past lifestyle habits
- Having previously received any treatments directed at the newly diagnosed EOGI cancer (i.e., at the time of inclusion, the patient has not yet started any type of treatment, excluding surgery)
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
新诊断的EoGI癌症患者
|
to characterize the distinctive features of EO-GI cancer through a comprehensive approach that considers clinical and demographic factors, tumor features, and patient lifestyle habits, in a real-world Italian settings, mainly located in Northern Italy |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary outcome
大体时间：One year from the enrollment
|
Describe clinical and tumor features of newly diagnosed EoGI cancer patients in a real-world Italian setting. |
One year from the enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Secondary outcome measure
大体时间：Six and twelve months follow-up
|
EoGI cancer type of treatment at diagnosis (chemotherapy, immunotherapy, targeted therapy, surgery, radiotherapy or best supportive care); progression of disease (if any) and survival status at 6 and 12 months follow-up. |
Six and twelve months follow-up
|
|
Secondary Outcome
大体时间：Two years
|
Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period |
Two years
|
|
Secondary Outcome
大体时间：One years from enrollment
|
Description of patients' lifetime exposure to behavioral and cancer-related risk factors |
One years from enrollment
|
|
Secondary Outcome
大体时间：One years from enrollment
|
Identify associations between past lifestyle habits (diet, physical activity, smoking, alcohol consumption,) and tumor-related features (stage, histology, anatomical site, and molecular markers) in EoGI cancer patients |
One years from enrollment
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.