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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
| 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 :
- 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 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
| 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 | 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
| 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 |
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
|
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| Study Groups/Cohorts |
|
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| 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 |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| 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 |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Zhao Weili, Ruijin Hospital | ||||||||
| Study Sponsor | Ruijin Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
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| PRS Account | Ruijin Hospital | ||||||||
| Verification Date | March 2020 | ||||||||
