Gastrointestinal LymphomaNCT03930043
A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
An observational study of Gastrointestinal Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Lymphoma
- What is being tested?
- Metagenomic shotgun sequencing
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The non-Hodgekin lymphoma patients with gastrointestinal involvement.
Who may be able to join
- Gastrointestinal lymphoma with a clarified pathological diagnosis
- De novo gastrointestinal lymphoma patients who haven't received chemotherapy
- BMI in normal range
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200023
Weili Zhao, MD,PhD, 64370045 ext. 610707, zhao.weili@yahoo.com
Pengpeng Xu, MD, 64370045 ext. 610707, xpproc@msn.com
About this study
This is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients.
Read the 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.
- Conditions
- Gastrointestinal Lymphoma
- Being tested
- Metagenomic shotgun sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic shotgun sequencingDiagnostic test
preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
| Study group | Role | What they receive |
|---|---|---|
| Health Control | Not described Receives: Diagnostic Test: Metagenomic shotgun sequencing | |
| Non-gastrointestinal Lymphoma | Not described Receives: Diagnostic Test: Metagenomic shotgun sequencing | |
| Gastric Lymphoma | Not described Receives: Diagnostic Test: Metagenomic shotgun sequencing | |
| Intestinal Lymphoma | Not described Receives: Diagnostic Test: Metagenomic shotgun sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomic Linkage Groups (MLGs)
A serial of genes in a metagenome that is probably physically linked as a microbial unit.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Mar 2017
- Primary completion30 Sep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, MD. PhD., Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930043
- Sponsor's protocol ID
- NHL-MGWAS
- Status last verified
- Mar 2020
- First submitted
- 25 Apr 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
- ClinicalTrials.gov ID
- NCT03930043
- Acronym / sponsor ID
- NHL-MGWAS
- Conditions
- Gastrointestinal Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The non-Hodgekin lymphoma patients with gastrointestinal involvement.
Key inclusion criteria (3 listed)
- Gastrointestinal lymphoma with a clarified pathological diagnosis
- De novo gastrointestinal lymphoma patients who haven't received chemotherapy
- BMI in normal range
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic shotgun sequencingpreforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen | Diagnostic test | Gastric Lymphoma, Health Control, Intestinal Lymphoma, Non-gastrointestinal Lymphoma |
Primary outcome
Metagenomic Linkage Groups (MLGs)
Time frame: 2 years
A serial of genes in a metagenome that is probably physically linked as a microbial unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weili Zhao, MD. PhD. study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengpeng Xu, MD. PhD. (86-21-64370045 ext. 610707, xpproc@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metagenomic Linkage Groups (MLGs) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.