免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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
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
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location 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
Layout table for location information
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
Layout table for investigator information
Study Chair: Weili Zhao, MD. PhD. Ruijin Hospital
Tracking Information
First Submitted Date April 25, 2019
First Posted Date April 29, 2019
Last Update Posted Date March 11, 2020
Actual Study Start Date March 1, 2017
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2019) 		Metagenomic Linkage Groups (MLGs) [ Time Frame: 2 years ]
A serial of genes in a metagenome that is probably physically linked as a microbial unit.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
Official Title A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The non-Hodgekin lymphoma patients with gastrointestinal involvement.
Condition Gastrointestinal Lymphoma
Intervention Diagnostic Test: Metagenomic shotgun sequencing
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
Study Groups/Cohorts
  • Health Control
    Intervention: Diagnostic Test: Metagenomic shotgun sequencing
  • Non-gastrointestinal Lymphoma
    Intervention: Diagnostic Test: Metagenomic shotgun sequencing
  • Gastric Lymphoma
    Intervention: Diagnostic Test: Metagenomic shotgun sequencing
  • Intestinal Lymphoma
    Intervention: Diagnostic Test: Metagenomic shotgun sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2019) 		160
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03930043
Other Study ID Numbers NHL-MGWAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Zhao Weili, Ruijin Hospital
Study Sponsor Ruijin Hospital
Collaborators Not Provided
Investigators
Study Chair: Weili Zhao, MD. PhD. Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date March 2020

治疗医院

新药特效药

治疗案例

前沿医讯