Clinical trial · Observational
Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer
Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer: a Study Protocol for Colorectal Neoplasms Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Introduction: Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. Traditional colonoscopy as an invasive examination method cannot be widely used in screening for colorectal neoplasia. The fecal immunochemical test has some limitations in sensitivity. Also, race and regional differences may affect results. Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiologic factor in the initiation and progression of colorectal cancer. Analyzing fecal flora and exfoliated cell genes may represent a new screening tool for colorectal cancer.This research aims to use 16S rRNA to compare differences in fecal flora between colorectal cancer patients and healthy controls. These data combined with DNA findings of fecal exfoliated cells may further clarify this difference to build a model for screening early colorectal cancer in Chinese people. Methods and analysis: In total, 300 patients with positive colonoscopy results and 200 health controls will be recruited. All participants will complete an information form and questionnaires. Fecal samples will be examined by 16S rRNA analysis. Gene methylation levels will be detected in fecal exfoliated cells. Models of related intestinal microbiota and methylation genes will be built. Receiver operating characteristic (ROC) curve analysis will be used to select some models with appropriate sensitivity and specificity.The models will be further validated by multicenter studys.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| DNA Methylation | — | UNRESOLVED | — |
| Gastrointestinal Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal microbiota detection and exfoliated cell gene detection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Healthy controls must be 18-75 years old with no tumors and no history of cancer.
- interventionNames
- Other: Fecal microbiota detection and exfoliated cell gene detection
- label
- Test Group
- description
- Inclusion criteria in the experimental group are age 18-75 years old, colonoscopy revealing colon or rectal tumor, biopsy-confirmed adenocarcinoma or adenoma, no chemotherapy or surgery, and no history of other cancer. Both groups must be able to understand and be willing to sign informed consent.
- interventionNames
- Other: Fecal microbiota detection and exfoliated cell gene detection
Primary outcomes (1)
- measure
- Diagnostic efficacy of colorectal cancer model in Chinese people
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * colonoscopy revealing colon or rectal tumor and biopsy-confirmed adenocarcinoma or adenoma. * no chemotherapy or surgery, and no history of other cancer. * must be able to understand and be willing to sign informed consent. * Healthy controls don't have tumors and history of cancer. Exclusion Criteria: * Those who not willing to provide specimens or answer questionnaires before the study began. * People whose stool samples does not meet the requirements. * People who are unwilling to sign written informed consent or follow a research protocol.
References
Publications (19)
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- RESULTSiegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1. PMID 28248415
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- RESULTSung JJ, Lau JY, Young GP, Sano Y, Chiu HM, Byeon JS, Yeoh KG, Goh KL, Sollano J, Rerknimitr R, Matsuda T, Wu KC, Ng S, Leung SY, Makharia G, Chong VH, Ho KY, Brooks D, Lieberman DA, Chan FK; Asia Pacific Working Group on Colorectal Cancer. Asia Pacific consensus recommendations for colorectal cancer screening. Gut. 2008 Aug;57(8):1166-76. doi: 10.1136/gut.2007.146316. PMID 18628378