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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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