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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03930043

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted March 11, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Gastrointestinal Lymphoma
  • Intervention/Treatment: Diagnostic Test: Metagenomic shotgun sequencing
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Estimated Enrollment: 160 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: December 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Gastric Lymphoma
Diagnostic Test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
: Health Control
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
: Non-gastrointestinal Lymphoma
Diagnostic Test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
Outcome Measures
  • Primary Outcome Measures: 1. Metagenomic Linkage Groups (MLGs) [ Time Frame: 2 years ]
    A serial of genes in a metagenome that is probably physically linked as a microbial unit.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: The non-Hodgekin lymphoma patients with gastrointestinal involvement.
Criteria

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

Contacts and Locations
Contacts

Contact: Pengpeng Xu, MD. PhD. 86-21-64370045 ext 610707 xpproc@msn.com

Contact: Mingci Cai, Master 86-21-13621999905 chinacmc_girl@hotmail.com

Locations

China, Shanghai
Shanghai Ruijin Hospital
Shanghai

Sponsors and Collaborators

Ruijin Hospital

Investigators

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

More Information
  • Responsible Party: Ruijin Hospital
  • ClinicalTrials.gov Identifier: NCT03930043 History of Changes
  • Other Study ID Numbers: NHL-MGWAS
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: March 11, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lymphoma Lymphoma, Non-Hodgkin