Clinical trial · Observational
Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer
NCT02845973CI-TRIAL-00041931completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gut microbiota | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- test cohort
- description
- The test cohort was from Fudan University Shanghai Cancer Center (August 2016 to December 2016) and ECRJ-East Campus of Renji hospital (January 2012 to March 2017);
- interventionNames
- Biological: gut microbiota
- label
- validation cohort
- description
- The validation cohort was from Shanghai Tenth People's Hospital (October 2015 to November 2016) and WCRJ-West Campus of Renji hospital (July 2016 to March 2017)
- interventionNames
- Biological: gut microbiota
Primary outcomes (1)
- measure
- differences in abundance of gut microbiota
- timeFrame
- 1 year
- description
- differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age from 40 to 85 years old * Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer * Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery Exclusion Criteria: * Patients with history of colorectal cancer * Patients with long term use of antibiotics or probiotics * Patients with uncontrolled diabetes, hypertension or hepatitis * Patients with a history of subtotal gastrectomy or partial bowel resection * Patients who are not able to cooperate * Patients with medical conditions who are not appropriate to participate the study * Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.
References
Publications (1)
- RESULTXie YH, Gao QY, Cai GX, Sun XM, Sun XM, Zou TH, Chen HM, Yu SY, Qiu YW, Gu WQ, Chen XY, Cui Y, Sun D, Liu ZJ, Cai SJ, Xu J, Chen YX, Fang JY. Fecal Clostridium symbiosum for Noninvasive Detection of Early and Advanced Colorectal Cancer: Test and Validation Studies. EBioMedicine. 2017 Nov;25:32-40. doi: 10.1016/j.ebiom.2017.10.005. Epub 2017 Oct 4. PMID 29033369