Determining Molecular Drivers of Radiation Dermatitis | NCT04764682

Studies
Determining Molecular Drivers of Radiation Dermatitis

NCT04764682

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 30, 2026Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2021Actual

Primary Completion Date

Mar 16, 2026Actual

Completion Date

Mar 16, 2026Actual

First Submitted Date

Feb 18, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 or a rash on swollen, reddened skin).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in skin	A skin punch biopsy will be obtained from a visible area of skin that harbors signs of clinical radiation.	Baseline, final week of radiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult women aged 18 years and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Vallow, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Jacksonville	Florida	32224	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Skin tissue. A 3mm punch biopsy will be collected at the time of surgery and during the final week of radiation treatment. One half of the sample will be placed in a separate cryovial container RNA later and the other half will be placed in a cryovial and flash frozen