Status:
COMPLETED
Observation of the Incidence and Natural History of MGUS in Patients Undergoing Weight Reduction Surgery
Lead Sponsor:
Indiana University
Conditions:
Monoclonal Gammopathy of Undetermined Significance
Eligibility:
All Genders
30+ years
Brief Summary
Screening study to determine incidence of MGUS in this patient population
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 12 2024
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT03855878
Start Date
December 10 2018
End Date
September 12 2024
Last Update
December 18 2024
Active Locations (1)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202