Radiation; ReactionNCT03287349
Genomic Assessment of Patients With Severe Radiation Reactions
An observational study of Radiation; Reaction, run by Mayo Clinic at 1 site in United States.
Trial summary
Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation; Reaction
- What is being tested?
- Blood draw, Photograph and Autoimmune testing
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 4 Jan 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults with severe reactions to radiation treatment
Who may be able to join
- Weigh at least 110 pounds
- Healthy
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.
- Conditions
- Radiation; Reaction
- Being tested
- Blood draw, Photograph, Autoimmune testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Two 12.5 mL blood draws
PhotographOther
Photograph of severe reaction, will be anonymized
Autoimmune testingDiagnostic test
Autoimmune testing in patients without prior testing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood draw; Other: Photograph; Diagnostic Test: Autoimmune testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole exome sequencing
Investigate genes potentially responsible for severe radiation reactions by getting blood draws.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start10 May 2017
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation; ReactionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Corbin, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287349
- Sponsor's protocol ID
- 16-004880
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2017
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Assessment of Patients With Severe Radiation Reactions
- ClinicalTrials.gov ID
- NCT03287349
- Acronym / sponsor ID
- 16-004880
- Conditions
- Radiation; Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 19 Sep 2017 (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.
Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe reactions to radiation | – | Other: Blood draw, Other: Photograph, Diagnostic Test: Autoimmune testingTwo 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults with severe reactions to radiation treatment
Key inclusion criteria (2 listed)
- Weigh at least 110 pounds
- Healthy
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawTwo 12.5 mL blood draws | Other | Patients with severe reactions to radiation |
| PhotographPhotograph of severe reaction, will be anonymized | Other | Patients with severe reactions to radiation |
| Autoimmune testingAutoimmune testing in patients without prior testing | Diagnostic test | Patients with severe reactions to radiation |
Primary outcome
Whole exome sequencing
Time frame: baseline
Investigate genes potentially responsible for severe radiation reactions by getting blood draws.
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 15 Nov 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kimberly Corbin, M.D. principal investigator
Mayo Clinic
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 Radiation; Reaction, run by Mayo Clinic 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 2 inclusion and 1 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 15 Nov 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?
Whole exome sequencing (time frame: baseline). 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 15 Nov 2024.