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This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative FIT, quantitative FIT, and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualitative FIT, quantitative FIT, and testing for new biomarkers | Diagnostic Test | Stool samples are collected from participants before endoscopy for qualitative FIT, quantitative FIT, and novel biomarker testing. The results are used to screen for gastrointestinal cancers. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening | At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll individuals aged 18 and older who are scheduled to undergo gastrointestinal endoscopy and are willing to participate in the screening.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng | Contact | +86 198 2975 8242 | zhengrong4956@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Air Force Military Medical University | Xi'an | Shaanxi | 710032 | China |
Once the study is complete, submit a request to the principal investigator. The applicant must provide a data analysis plan, and a decision on whether to share the data will be made following an evaluation.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 25, 2025 | May 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 25, 2025 | May 13, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |