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

Indiana University

Status: Completed

Conditions: Monoclonal Gammopathy of Undetermined Significance

Study type: Observational

Funder types: Other

Identifiers

NCT03855878

IUSCC-0633

Details and patient eligibility

About

Screening study to determine incidence of MGUS in this patient population

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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