A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients

• Conditions: Gastrointestinal Lymphoma

• Registration Number: NCT03930043
• Lead Sponsor: Ruijin Hospital

Brief Summary

This is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients.

Detailed Description

This observation study is aimed at investigating the gut microbiota alteration in gastrointestinal lymphoma (GIL) patients by performing metagenomic shotgun sequencing on GIL patients' fecal specimen. Before immuno-chemotherapy, the feces specimen of GIL would be collected and stored for further laboratory examination. This study would NOT alter the subsequential treatment of the patients.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-09-30
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Gastrointestinal lymphoma with a clarified pathological diagnosis
• De novo gastrointestinal lymphoma patients who haven't received chemotherapy
• BMI in normal range

Exclusion Criteria

• Antibiotics or probiotics application within a month
• Overweight (BMI≥25) or malnourished (BMI<18.5) patients
• Patients who have been accepted gastrointestinal fistulation
• Gastrointestinal patients with inflammatory bowel disease (IBD), colorectal carcinoma (CRC) or any other chronic intestinal disease
• Patients infected by HIV

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metagenomic Linkage Groups (MLGs)	2 years	A serial of genes in a metagenome that is probably physically linked as a microbial unit.

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China