Genomic Assessment of Patients With Severe Radiation Reactions

NCT03287349 | Completed

• 1 other identifier: 16-004880
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Radiation; Reaction

Outcome Measures

Primary Outcomes (1)

• Whole exome sequencing

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

  baseline

Study Arms (1)

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; Other: Photograph; Diagnostic Test: Autoimmune testing

Interventions

Blood draw OTHER

Two 12.5 mL blood draws

Patients with severe reactions to radiation

Photograph OTHER

Photograph of severe reaction, will be anonymized

Patients with severe reactions to radiation

Autoimmune testing DIAGNOSTIC_TEST

Autoimmune testing in patients without prior testing

Patients with severe reactions to radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with severe reactions to radiation treatment

You may qualify if:

• Weigh at least 110 pounds
• Healthy

You may not qualify if:

• \- Pregnant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Blood Specimen Collection; Moire Topography

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Photogrammetry; Photography; Diagnostic Imaging; Interferometry

Study Officials

• Kimberly Corbin, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: May 10, 2017
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)