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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03855878

Enrollment

209

Registered

2019-02-27

Start date

2018-12-10

Completion date

2024-09-12

Last updated

2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

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 physician monitored weight loss program and to follow the regression or progression of MGUS following surgery or the initiation of the weight loss program.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results