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

NCT03855878 | Completed DMC

• 1 other identifier: IUSCC-0633
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

Screening study to determine incidence of MGUS in this patient population

Conditions

Monoclonal Gammopathy of Undetermined Significance

Outcome Measures

Primary Outcomes (1)

• Rate of MGUS

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

  5 years

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To evaluate the incidence of MGUS in obese subjects 30 years and older planning to undergo weight reduction surgery or who have agreed to enter into a physician monitored weight loss program.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

If patients are qualified for the study and elect to submit a sample for DNA it will be collected and stored at the Indiana biobank

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rafat Abonour, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: December 10, 2018
• Primary Completion: February 17, 2022
• Study Completion: September 12, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)