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

March 9, 2020 updated by: Zhao Weili, Ruijin Hospital
This is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200023
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The non-Hodgekin lymphoma patients with gastrointestinal involvement.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health Control
Diagnostic test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
Non-gastrointestinal Lymphoma
Diagnostic test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
Gastric Lymphoma
Diagnostic test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
Intestinal Lymphoma
Diagnostic test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metagenomic Linkage Groups (MLGs)
Time Frame: 2 years
A serial of genes in a metagenome that is probably physically linked as a microbial unit.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Weili Zhao, MD. PhD., Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL-MGWAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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