Genomic Assessment of Patients With Severe Radiation Reactions

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03287349
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 71.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radiation; Reaction	Other: Blood draw; Other: Photograph; Diagnostic Test: Autoimmune testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Genomic Assessment of Patients With Severe Radiation Reactions
• Actual Study Start Date: May 10, 2017
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Whole exome sequencing [baseline]

   Investigate genes potentially responsible for severe radiation reactions by getting blood draws.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Weigh at least 110 pounds

• Healthy

Exclusion Criteria:

• Pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Kimberly S. Corbin, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03287349
• Other Study ID Numbers: 16-004880
• First Posted: Sep 19, 2017
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 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

Study Results

No Results Posted as of Sep 14, 2021