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

Gastrointestinal Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03930043
• Other study ID #: NHL-MGWAS
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: Pengpeng Xu, MD. PhD.
• Phone: 86-21-64370045
• Email: xpproc[@]msn.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Diagnostic Test:
• Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metagenomic Linkage Groups (MLGs)	A serial of genes in a metagenome that is probably physically linked as a microbial unit.	2 years