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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-10

Study Completion Date

2024-09-12

Brief Summary

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Screening study to determine incidence of MGUS in this patient population

Detailed Description

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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.

Conditions

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Monoclonal Gammopathy of Undetermined Significance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rafat Abonour

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafat Abonour, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IUSCC-0633

Identifier Type: -

Identifier Source: org_study_id