Circulating Tumor DNA and Immunophenotyping as Potential... | NCT04308720

Studies
Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer

NCT04308720

Sponsor

Mayo Clinic

Status

Active, not recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

217Actual

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

ID	Type	Description	Link
ROR1931	Other Identifier	Mayo Clinic Radiation Oncology

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Oct 20, 2028Estimated

Completion Date

Oct 20, 2028Estimated

First Submitted Date

Feb 7, 2020

First Submission Date that Met QC Criteria

Mar 13, 2020

First Posted Date

Mar 16, 2020Actual

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

Jun 16, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.

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

No data available

No data is available for this block.

Enrollment

217Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the ctDNA detection	Assessed by the number of patients who have undetectable ctDNA post-treatment, among patients that were detectable pre-treatment.	Baseline to 3 months post-treatment (treatment typically lasts 3-6 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Explore correlation of detectable ctDNA with invasive recurrence-free survival	Invasive recurrence is defined as the return of cancer after initial treatment, where the cancer has spread beyond the ducts or lobules into surrounding breast tissue	3 months post-treatment (treatment typically lasts 3-6 weeks)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.
Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=< 3 sites of metastases) is permitted
Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts
Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
Bilateral breast cancer is permitted
Positive or close margins is allowed

Exclusion Criteria:

Other active malignancy =< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)
Pregnancy or lactation
Inability on the part of the patient to understand the informed consent to be compliant with the protocol

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Women ages 18 and older with high-risk breast cancer with plan for adjuvant radiation therapy including the regional lymph nodes at Mayo Clinic.

Sampling Method

Non-Probability Sample

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