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

Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery

Screening study to determine incidence of MGUS in this patient population

Study Overview

• Status: Completed
• Conditions: Monoclonal Gammopathy of Undetermined Significance

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.

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To evaluate the incidence of MGUS in obese subjects 30 years and older planning to undergo weight reduction surgery or who have agreed to enter into a physician monitored weight loss program.

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of MGUS	The primary analysis focuses on the estimation of the rate of MGUS for this specific population.	5 years

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Rafat Abonour, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Immune System Diseases; Body Weight Changes; Hematologic Diseases; Immunoproliferative Disorders; Blood Protein Disorders; Hypergammaglobulinemia; Weight Loss; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
• Other Study ID Numbers: IUSCC-0633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No