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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930043
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

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

Condition or disease Intervention/treatment
Gastrointestinal Lymphoma Diagnostic Test: Metagenomic shotgun sequencing

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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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 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930043


Contacts
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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
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China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200023
Contact: Weili Zhao, MD,PhD    64370045 ext 610707    zhao.weili@yahoo.com   
Contact: Pengpeng Xu, MD    64370045 ext 610707    xpproc@msn.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Study Chair: Weili Zhao, MD. PhD. Ruijin Hospital
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Responsible Party: Zhao Weili, Deputy Director of Hematology Department, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03930043    
Other Study ID Numbers: NHL-MGWAS
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases