Observation of the Incidence and Natural History of MGUS in Patients Undergoing Weight Reduction Surgery

Completed

• Conditions: Monoclonal Gammopathy of Undetermined Significance

• Registration Number: NCT03855878
• Lead Sponsor: Indiana University

Brief Summary

Screening study to determine incidence of MGUS in this patient population

Detailed Description

This study is designed to observe the incidence of monoclonal gammopathy of undetermined significance (MGUS) among obese patients planning to have weight reduction surgery or planning to enter into a physician monitored weight loss program and to follow the regression or progression of MGUS following surgery or the initiation of the weight loss program.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Primary Completion: 2022-02-17
• Study Completion: 2024-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

1. Male or female patients 30 years or older planning to undergo weight reduction surgery or planning to enter into a physician monitored weight loss program

2. Patients must be obese, defined as a BMI ≥ 30 as calculated by the formula:

   weight in pounds / height squared x 703 = BMI

3. Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines.

4. To remain in the study for the follow-up phase, the baseline screening test must indicate that a patient has MGUS.

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Exclusion Criteria

1. No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
2. No concurrent or planned participation in randomized trials of weight loss.
3. A patient will be excluded from the follow-up phase if the baseline screening test indicates they do not have MGUS

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of MGUS	5 years	The primary analysis focuses on the estimation of the rate of MGUS for this specific population.

Trial Locations

Locations (1)

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States