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Status unknownNCT03930043Updated Mar 11, 2020

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

An observational study in Gastrointestinal Lymphoma, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by Ruijin Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Gastrointestinal Lymphoma
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 160 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The non-Hodgekin lymphoma patients with gastrointestinal involvement.

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • Health Control

    Diagnostic Test: Metagenomic shotgun sequencing

  • Non-gastrointestinal Lymphoma

    Diagnostic Test: Metagenomic shotgun sequencing

  • Gastric Lymphoma

    Diagnostic Test: Metagenomic shotgun sequencing

  • Intestinal Lymphoma

    Diagnostic Test: Metagenomic shotgun sequencing

Interventions

  • Diagnostic testMetagenomic shotgun sequencing

    preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen

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What researchers measure

Primary outcomes

  1. Metagenomic Linkage Groups (MLGs)

    A serial of genes in a metagenome that is probably physically linked as a microbial unit.

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Shanghai Ruijin Hospital
    Shanghai, Shanghai 200023, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03930043
Lead sponsor
Ruijin Hospital
Responsible party
Zhao Weili (Deputy Director of Hematology Department, Ruijin Hospital) — Principal investigator
First posted
Apr 29, 2019
Start date
Mar 1, 2017
Primary completion
Sep 30, 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Mar 11, 2020

Study contacts

Pengpeng Xu, MD. PhD.
Contact
xpproc@msn.com
86-21-64370045 ext. 610707
Mingci Cai, Master
Contact
chinacmc_girl@hotmail.com
86-21-13621999905
Weili Zhao, MD. PhD.
study chair · Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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