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

NCT ID: NCT03930043

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastrointestinal Lymphoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Health Control

Metagenomic shotgun sequencing

Intervention Type DIAGNOSTIC_TEST

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

Non-gastrointestinal Lymphoma

Metagenomic shotgun sequencing

Intervention Type DIAGNOSTIC_TEST

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

Gastric Lymphoma

Metagenomic shotgun sequencing

Intervention Type DIAGNOSTIC_TEST

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

Intestinal Lymphoma

Metagenomic shotgun sequencing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Metagenomic shotgun sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

Deputy Director of Hematology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weili Zhao, MD. PhD.

Role: STUDY_CHAIR

Ruijin Hospital

Locations

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Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pengpeng Xu, MD. PhD.

Role: CONTACT

86-21-64370045 ext. 610707

Mingci Cai, Master

Role: CONTACT

86-21-13621999905

Facility Contacts

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Weili Zhao, MD,PhD

Role: primary

64370045 ext. 610707

Pengpeng Xu, MD

Role: backup

64370045 ext. 610707

Other Identifiers

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NHL-MGWAS

Identifier Type: -

Identifier Source: org_study_id

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