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

Completed

Conditions studied: Monoclonal Gammopathy of Undetermined Significance

In brief

Screening study to determine incidence of MGUS in this patient population

Key facts

Study ID

NCT03855878

Run by

Indiana University

People needed

209

Starts

2018-12-10

Expected to finish

2024-09-12

Last updated by the study team

2024-12-18

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients must be obese, defined as a BMI ≥ 30 as calculated by the formula:
• weight in pounds / height squared x 703 = BMI
• Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines.
• To remain in the study for the follow-up phase, the baseline screening test must indicate that a patient has MGUS.

You may not qualify if…

• 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.
• No concurrent or planned participation in randomized trials of weight loss.
• A patient will be excluded from the follow-up phase if the baseline screening test indicates they do not have MGUS

Where it is running

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

Full record on ClinicalTrials.gov

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