早期発症胃腸癌に関する前向き観察研究：腫瘍の特徴から患者の生活習慣まで (YOGICO)
早期発症消化器癌に関する前向き観察研究：腫瘍特徴から患者の生活習慣まで - 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
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ilaria Bernardini, MD
- 電話番号：+39 059659294
- メール：i.bernardini@ausl.mo.it
研究場所
-
-
BO
-
Bologna、BO、イタリア
- まだ募集していません
- Oncologia, Ospedale Sant'Orsola
-
コンタクト：
- Karim Rihawi, MD
-
-
FC
-
Meldola、FC、イタリア
- 積極的、募集していない
- Istituto Romagnolo per lo studio dei tumori "Dino Amadori", IRCCS IRST
-
-
MO
-
Carpi、MO、イタリア
- 募集
- Oncologia di Prossimità, Ospedale di Carpi e DHO Mirandola, Ausl Modena
-
コンタクト：
- Claudia Mucciarini, MD
-
Modena、MO、イタリア
- 積極的、募集していない
- Centro Oncologico Modenese, Azienda Policlinico Universitaria di Modena
-
Sassuolo、MO、イタリア
- 募集
- Oncologia Area Sud Ausl Modena
-
コンタクト：
- Teresa Zielli, MD
-
-
Minnesota
-
Mantua、Minnesota、イタリア
- 積極的、募集していない
- Oncologia Ospedale Carlo Poma di Mantova
-
-
PC
-
Piacenza、PC、イタリア
- 積極的、募集していない
- Oncologia Medica, AUSL Piacenza
-
-
PR
-
Parma、PR、イタリア
- 募集
- Oncologia, Azienda Ospedaliero Universitaria di Parma
-
コンタクト：
- Annalisa Gilli, MD
-
-
RE
-
Reggio Emilia、RE、イタリア
- 募集
- Oncologia Medica, CORE Azienda USL-IRCCS Reggio Emilia
-
コンタクト：
- Francesco Caputo, MD
-
-
RN
-
Rimini、RN、イタリア
- 募集
- Oncologia, Ospedale di Rimini
-
コンタクト：
- Francesca Fabbri, MD
-
-
VA
-
Varese、VA、イタリア
- まだ募集していません
- Oncologia, ASST SETTE LAGHI, Ospedale di Circolo
-
コンタクト：
- Michele Ghidini, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
新たに診断されたEoGIがん患者
|
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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary outcome
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary outcome measure
時間枠：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
時間枠：Two years
|
Incidence and prevalence of newly diagnosed EoGI cancer at each participating site during the study accrual time period |
Two years
|
|
Secondary Outcome
時間枠：One years from enrollment
|
Description of patients' lifetime exposure to behavioral and cancer-related risk factors |
One years from enrollment
|
|
Secondary Outcome
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。