Clinical trial · Observational
Study of Faecal Bacteria Detection in Early Screening and Diagnosis of GC
Faecal Bacteria Detection in Early Screening and Diagnosis of Gastric Cancer: a Large-scale Multi-center Case-control Study
- 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)
In this clinical trial, we aim to explore the synergistic alteration of specific bacteria both in gastric mucosas and feces of gastric cancer patients for the method of non-invasive and cost-effective faecal marker detection. We aim to select and validate specific microbes as noninvasive, accurate, simple, sensitive and highly-accepted biomarkers that might assist to screen and diagnose gastric cancer, especially early gastric cancer patients.
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 |
|---|---|---|---|
| Non-invasive and Sensitive Faecal Bacterial Markers for Early Screening and Diagnosis of Gastric Cancer | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| collect gastric tissue and stool samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- GC
- description
- patients diagnosed with GC
- interventionNames
- Other: collect gastric tissue and stool samples
- label
- HC
- description
- patients diagnosed with chronic gastritis by histopathology
- interventionNames
- Other: collect gastric tissue and stool samples
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)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1)Age between 40 and 75; * 2)Subjects in GC group are pathologically diagnosed as gastric cancer prior to any treatment such as surgery, endoscopic resection, chemotherapy, radiotherapy, immunotherapy, traditional Chinese medicine therapy, etc. The results of their preoperative abdominal enhanced CT or PET-CT indicated no obvious bowel abnormalities (inflammation, polyps, ulcers, tumors, erosions, melanosis, etc.); * 3\) Subjects in HC group are diagnosed with chronic gastritis by endoscopy and pathology. without ulcers, polyps, tumors, severe erosions or bile reflux, and no obvious abnormal findings (inflammation, polyps, ulcers, tumors, erosions, melanosis, etc.) by colonoscopy within half a year; * 4\) Subjects are willing to cooperate with this research and provide stool/mucosa samples as required. Exclusion Criteria: * 1\) with severe systemic infection, nasopharyngeal/oral cavity inflammation (periodontitis, gingivitis, tonsillitis, etc.), respiratory tract infection, soft tissue or skin infection, abscess or endocarditis within 3 months prior to recruitment; * 2)prior medication history of the following medicine within 3 months: nonsteroidal anti-inflammatory drugs (NSAIDs), immunosuppressor, antibiotics, probiotics, hormones or immune-suppressants at least 1 week; * 3)prior medication history of proton-pump inhibitors or H2 receptor inhibitors for over 2 months within 1 year; * 4\) with a history of H.pylori eradication therapy within 1 year; * 5\) with severe constipation, diarrhea or defecation habits changes within 3 months; * 6\) personal history of cancer, organ transplantation, parasites infection or other severe digestive system diseases (inflammatory bowel disease, liver cirrhosis, etc.); * 7\) with uncontrolled digestive bleeding, obstruction, perforation and any trauma or surgery within 3 months; * 8\) with uncontrolled chronic metabolic or endocrine disorders, e.g. hypertension, diabetes, hyperlipidemia, hyperuricemia, etc. * 9\) on a vegetarian diet or with great changes of eating habits within 3 months; * 10\) refusal of participate in this study.
References
Publications (1)
- DERIVEDZhou CB, Pan SY, Jin P, Deng JW, Xue JH, Ma XY, Xie YH, Cao H, Liu Q, Xie WF, Zou XP, Sheng JQ, Wang BM, Wang H, Ren JL, Liu SD, Sun YW, Meng XJ, Zhao G, Chen JX, Cui Y, Wang PQ, Guo HM, Yang L, Chen X, Ding J, Yang XN, Wang XK, Qian AH, Hou LD, Wang Z, Chen YX, Fang JY. Fecal Signatures of Streptococcus anginosus and Streptococcus constellatus for Noninvasive Screening and Early Warning of Gastric Cancer. Gastroenterology. 2022 Jun;162(7):1933-1947.e18. doi: 10.1053/j.gastro.2022.02.015. Epub 2022 Feb 12. PMID 35167866