Breast CancerNCT04764682
Determining Molecular Drivers of Radiation Dermatitis
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2021to 16 Mar 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women aged 18 years and older
Who may be able to join
- Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment.
- Tissue diagnosis of breast cancer.
- Age > 18 years
- Signed informed consent.
- Complete blood count within normal limits within the preceding 2 weeks.
Who cannot join
- Induction chemotherapy or biologic therapy
- Concurrent chemotherapy or biologic therapy
- Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis
- Allergy to lidocaine anesthesia
- Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia)
- History of keloids or easy scarring
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin
A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.
Measured: Baseline, final week of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start21 Feb 2021
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura A. Vallow, Mayo Clinic
- Investigators
- Laura Vallow, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764682
- Sponsor's protocol ID
- 19-005445
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2021
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Molecular Drivers of Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT04764682
- Acronym / sponsor ID
- 19-005445
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 21 Feb 2021 (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.
This study is being conducted to address key gaps in current knowledge and set the stage for rational design of strategies to prevent (pre-exposure to radiation), mitigate (post-exposure to radiation before overt signs/symptoms appear), and/or treat (post-onset of signs/symptoms) radiation dermatitis (itchy, dry skin or a rash on swollen, reddened skin).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women aged 18 years and older
Key inclusion criteria (5 listed)
- Patients receiving standard-of-care postoperative radiation therapy (2-2.7 Gy per fraction) to the breast and/or chest wall for breast cancer treatment.
- Tissue diagnosis of breast cancer.
- Age > 18 years
- Signed informed consent.
- Complete blood count within normal limits within the preceding 2 weeks.
Key exclusion criteria (6 listed)
- Induction chemotherapy or biologic therapy
- Concurrent chemotherapy or biologic therapy
- Autoimmune disease with skin manifestations - psoriasis, dermatomyositis, scleroderma, eczema, polymyositis
- Allergy to lidocaine anesthesia
- Known bleeding diathesis (anticoagulation with warfarin, coagulation/bleeding disorders, vitamin C or K deficiency, thrombocytopenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in skin
Time frame: Baseline, final week of radiation
A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.
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 30 Mar 2026.
- 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.
Laura Vallow, MD 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 Breast Cancer, 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 5 inclusion and 6 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 30 Mar 2026. 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?
Change in skin (time frame: Baseline, final week of radiation). 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 30 Mar 2026.