Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02845973

Enrollment

1325

Registered

2016-07-27

Start date

2012-01-31

Completion date

2017-07-31

Last updated

2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

gut microbiota

Brief summary

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.

Detailed description

Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression of CRCs (colorectal cancers). Subsequent research shows identifying multiple microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction) may help diagnosis of early stage colorectal cancer. Currently little is known about the relationship between single abundance of specific gut microbiota and colorectal cancer in different stage. Moreover, finding early-stage CRCs is still of great challenge partially due to precancerous diseases like colorectal adenoma which remain difficult to differentiate from early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of adequate sensitivity and specificity especially in early stage CRCs. The investigators' work focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its comparison with classical indicators such as CEA and OB, aiming to reveal and testify its potential role on assisting diagnosis of CRCs in different stage as a none-invasive cost-effective method.

Interventions

BIOLOGICALgut microbiota

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to 99 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
differences in abundance of gut microbiota	1 year	differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)

Secondary

Measure	Time frame	Description
evidence of colorectal neoplasia	1 year	Different outcomes for colorectal neoplasia confirmed by coloscopy

Other

Measure	Time frame	Description
diet difference in patients with different clinical outcomes	1 year	Diet difference in patients with different clinical outcomes by a food-frequency questionnaire

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026