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

Monoclonal Gammopathy of Undetermined Significance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03855878
• Other study ID #: IUSCC-0633
• Status: Active, not recruiting
• Start date: November 8, 2018
• Est. completion date: August 8, 2024

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Screening study to determine incidence of MGUS in this patient population

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 209
• Est. completion date: August 8, 2024
• Est. primary completion date: August 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Paraproteinemias
• Weight Loss

Locations

Country	Name	City	State
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MGUS	The primary analysis focuses on the estimation of the rate of MGUS for this specific population.	5 years