Genomic Assessment of Patients With Severe Radiation Reactions

November 13, 2024 updated by: Mayo Clinic
Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

adults with severe reactions to radiation treatment

Description

Inclusion Criteria:

  • Weigh at least 110 pounds
  • Healthy

Exclusion Criteria:

- Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with severe reactions to radiation
Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing.
Other: Blood draw
Two 12.5 mL blood draws
Other: Photograph
Photograph of severe reaction, will be anonymized
Diagnostic test: Autoimmune testing
Autoimmune testing in patients without prior testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole exome sequencing
Time Frame: baseline
Investigate genes potentially responsible for severe radiation reactions by getting blood draws.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kimberly Corbin, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

January 4, 2023

Study Completion (Actual)

January 4, 2023

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 16-004880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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