Genomic Assessment of Patients With Severe Radiation Reactions

Completed

• Conditions: Radiation; Reaction
• Interventions: Other: Blood draw; Other: Photograph; Diagnostic Test: Autoimmune testing

• Registration Number: NCT03287349
• Lead Sponsor: Mayo Clinic

Brief Summary

Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Weigh at least 110 pounds
• Healthy

Exclusion Criteria

• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe reactions to radiation	Blood draw	Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing.
Patients with severe reactions to radiation	Photograph	Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing.
Patients with severe reactions to radiation	Autoimmune testing	Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing.

Primary Outcome Measures

Name	Time	Method
Whole exome sequencing	baseline	Investigate genes potentially responsible for severe radiation reactions by getting blood draws.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States