Monoclonal Gammopathy of Undetermined SignificanceNCT03855878
Observation of the Incidence and Natural History of MGUS in Patients Undergoing Weight Reduction Surgery
An observational study of Monoclonal Gammopathy of Undetermined Significance, run by Indiana University at 1 site in United States.
Trial summary
Screening study to determine incidence of MGUS in this patient population Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 12 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery
Screening study to determine incidence of MGUS in this patient population
Read the 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.
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MGUS
The primary analysis focuses on the estimation of the rate of MGUS for this specific population.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start10 Dec 2018
- Primary completion17 Feb 2022
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafat Abonour, Indiana University
- Investigators
- Rafat Abonour, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855878
- Sponsor's protocol ID
- IUSCC-0633
- Status last verified
- Oct 2024
- First submitted
- 25 Feb 2019
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation of the Incidence and Natural History of Monoclonal Gammopathy in Patients Undergoing Weight Reduction Surgery
- ClinicalTrials.gov ID
- NCT03855878
- Acronym / sponsor ID
- IUSCC-0633
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of MGUS
Time frame: 5 years
The primary analysis focuses on the estimation of the rate of MGUS for this specific population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No. Individual patient data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafat Abonour, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathy of Undetermined Significance, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MGUS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.