A Metagenome-wide Association Study of Gut Microbiota in... | NCT03930043

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

NCT03930043

Sponsor

Ruijin Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2020Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Gastrointestinal Lymphoma

Interventions

Metagenomic shotgun sequencing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Apr 25, 2019

First Submission Date that Met QC Criteria

Apr 25, 2019

First Posted Date

Apr 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metagenomic shotgun sequencing	Diagnostic Test	preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen	Gastric Lymphoma Health Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metagenomic Linkage Groups (MLGs)	A serial of genes in a metagenome that is probably physically linked as a microbial unit.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

The non-Hodgekin lymphoma patients with gastrointestinal involvement.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pengpeng Xu, MD. PhD.	Contact	86-21-64370045	610707	xpproc@msn.com
Mingci Cai, Master	Contact	86-21-13621999905		chinacmc_girl@hotmail.com

Overall Officials

Name	Affiliation	Role
Weili Zhao, MD. PhD.	Ruijin Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ruijin Hospital	Recruiting	Shanghai	Shanghai Municipality	200023	China