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

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03855878
Collaborator
(none)
30
Enrollment
1
Location
69
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Screening study to determine incidence of MGUS in this patient population

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery
    Actual Study Start Date :
    Nov 8, 2018
    Anticipated Primary Completion Date :
    Aug 8, 2024
    Anticipated Study Completion Date :
    Aug 8, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Rate of MGUS [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines.

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Simon Cancer Center Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Rafat Abonour, MD, Indiana University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rafat Abonour, Professor of Medicine, Indiana University
    ClinicalTrials.gov Identifier:
    NCT03855878
    Other Study ID Numbers:
    • IUSCC-0633
    First Posted:
    Feb 27, 2019
    Last Update Posted:
    Jun 28, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Paraproteinemias
    Monoclonal Gammopathy of Undetermined Significance
    Weight Loss

    Study Results

    No Results Posted as of Jun 28, 2021