Noninvasive Early Diagnosis of Colorectal Cancer Using Odor-Targeted Capture, Point-of-Care Testing, and Intelligent Analysis
Key Technology Research on Non-invasive Early Diagnosis of Colorectal Cancer Based on Odor-targeted Capture, Instant Detection, and Intelligent Analysis
The goal of this observational study is to see whether a new, noninvasive test that analyzes smells (odor) from breath and intestinal gas can help detect colorectal cancer and precancerous growths at an early stage.
The main questions it aims to answer are:
Can the new odor-based test correctly identify people who have colorectal cancer or precancerous lesions?
How accurate is the new test compared to the current standard method (colonoscopy with biopsy)?
Researchers will compare the results of the new test with standard diagnostic results.
Participants will be asked to:
Provide samples of breath, urine, stool, and intestinal gas (collected using a special device or a collection bag)
Allow researchers to review their medical records and colonoscopy results
Answer questions about their health history and lifestyle
This study involves no treatments or procedures beyond normal medical care. It only collects samples and data for research purposes.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Mei Zhang
- 電話番号:13810021517
- メール:meizhang@bucm.edu.cn
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- Beijing University of Chinese Medicine
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コンタクト:
- Mei Zhang
- 電話番号:+8613810021517
- メール:meizhang@bucm.edu.cn
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
The study population will consist of three groups recruited primarily from Beijing University of Chinese Medicine, Dongfang Hospital:
Patients with histopathologically confirmed colorectal cancer (TNM stage I-IV).
Patients with histopathologically confirmed precancerous lesions (e.g., colorectal adenomas, sessile serrated lesions).
Healthy controls with no abnormalities on colonoscopy within the past year and no history of colorectal cancer or other malignancies.
Participants will be adults aged 18 to 85 years. Healthy controls will be recruited from the same hospital settings and matched for key demographic factors (age, sex, BMI) and lifestyle habits to minimize confounding.
説明
Inclusion Criteria:
- Age 18 to 85 years, male or female
- Histopathologically or cytologically confirmed colon or rectal cancer (TNM stage I-IV) for colorectal cancer group
- Histopathologically confirmed adenomatous polyps, sessile serrated lesions, traditional serrated adenomas, or other precancerous lesions for precancerous lesion group
- No abnormality on colonoscopy within the past year; no personal history of colorectal cancer or other malignancies; no chronic diseases requiring long-term treatment for healthy control group
- Willing and able to provide signed informed consent
Exclusion Criteria:
- Hereditary colorectal cancer syndromes (e.g., familial adenomatous polyposis, hereditary non-polyposis colorectal cancer)
- Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis)
- Severe cardiovascular, respiratory, or urinary system diseases
- Other primary malignant tumors
- Hematological diseases
- Unable to comply with study procedures (e.g., sample collection or questionnaires)
- Planning to become pregnant, pregnant, or breastfeeding
- Suspected or confirmed alcohol or drug abuse
- Known allergy to any drug used for colorectal cancer treatment
- Participation in another interventional drug clinical trial within the past month
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study
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
コホートと介入
グループ/コホート |
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健康管理
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大腸がん
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Precancerous Lesion
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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 |
時間枠 |
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Diagnostic accuracy of the odor-based test using volatile organic compounds (VOCs) for detecting colorectal cancer and precancerous lesions
時間枠:Baseline
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Baseline
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Li Z, Li Y, Zhan L, Meng L, Huang X, Wang T, Li Y, Nie Z. Point-of-Care Test Paper for Exhaled Breath Aldehyde Analysis via Mass Spectrometry. Anal Chem. 2021 Jul 6;93(26):9158-9165. doi: 10.1021/acs.analchem.1c01011. Epub 2021 Jun 24.
- Hanevelt J, Schoenaker IJH, Brohet RM, Schrauwen RWM, Baas FJN, Tanis PJ, van Westreenen HL, de Vos Tot Nederveen Cappel WH. Alteration of the Exhaled Volatile Organic Compound Pattern in Colorectal Cancer Patients after Intentional Curative Surgery-A Prospective Pilot Study. Cancers (Basel). 2023 Sep 29;15(19):4785. doi: 10.3390/cancers15194785.
- Chung J, Akter S, Han S, Shin Y, Choi TG, Kang I, Kim SS. Diagnosis by Volatile Organic Compounds in Exhaled Breath in Exhaled Breath from Patients with Gastric and Colorectal Cancers. Int J Mol Sci. 2022 Dec 21;24(1):129. doi: 10.3390/ijms24010129.
研究記録日
主要日程の研究
研究開始 (推定)
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。