Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders (Microbiome)
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| ClinicalTrials.gov Identifier: NCT06252948 |
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Recruitment Status :
Recruiting
First Posted : February 12, 2024
Last Update Posted : February 13, 2024
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Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Mayo Clinic
| Tracking Information | |||||||||
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| First Submitted Date | February 2, 2024 | ||||||||
| First Posted Date | February 12, 2024 | ||||||||
| Last Update Posted Date | February 13, 2024 | ||||||||
| Actual Study Start Date | December 29, 2021 | ||||||||
| Estimated Primary Completion Date | December 1, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders [ Time Frame: Baseline ] Stool samples will be collected by the patient using a stool self- collection kit provided to the participant by the study staff. Samples will be evaluated for characteristics of gut microbiome (α-diversity and β-diversity).
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| 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 | Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders | ||||||||
| Official Title | Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders | ||||||||
| Brief Summary | A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders | ||||||||
| Detailed Description | The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Stool donation will be requested from participants to assess gut microbiome
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | POEMS Syndrome and Other Plasma Cell Disorders | ||||||||
| Condition | Plasma Cell Disorders | ||||||||
| Intervention | Other: Gut microbiome studies in patients with POEMS syndrome and other plasma cell disorders.
None-Collection of samples for future analysis
Other Name: GMB
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
240 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 29, 2028 | ||||||||
| Estimated Primary Completion Date | December 1, 2028 (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 and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT06252948 | ||||||||
| Other Study ID Numbers | 20-013316 NCI-2022-10547 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Mayo Clinic | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Mayo Clinic | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Mayo Clinic | ||||||||
| Verification Date | February 2024 | ||||||||