Skip to main content
OpenTrials
Completed

NCT Number: NCT03855878

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

Screening study to determine incidence of MGUS in this patient population

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Rate of MGUS

    Time frame: 5 years

    The primary analysis focuses on the estimation of the rate of MGUS for this specific population.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Feb 27, 2019
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.