Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Tempus AI
Study ID
NCT07211178
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer
  • Early Stage Breast Cancer
  • HER2 + Breast Cancer
  • HR Positive/HER-2 Negative Breast Cancer
  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • There are no interventions in this observational study. — OTHER
    There are no interventions in this observational study.

Study Details

For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later. A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working. Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.

Key Dates

Start date
Oct 27, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2032
Completion
Dec 31, 2033

Study Design

Enrollment
900 participants (estimated)

Arms

  • Arm: Cohort 1: Neoadjuvant Therapy
    There are no interventions in this observational study. Cohort 1 includes participants who will receive neoadjuvant treatment prior to surgery.
  • Arm: Cohort 2: Adjuvant Therapy / Surveillance
    There are no interventions in this observational study. Cohort 2 includes participants who will receive adjuvant therapy after surgery.
  • Arm: Cohort 3: 5 Years Post-Diagnosis Surveillance
    There are no interventions in this observational study. Cohort 3 includes participants who have no evidence of disease for at least 5 years post diagnosis.

Primary Outcome Measure

Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up [ Time Frame: 5 years ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Birmingham Hematology AssociatesBirminghamAlabama35223
Amanda Joseph
[email protected]
Matthew Tucker (PRINCIPAL_INVESTIGATOR)
PIH Health Whittier HospitalWhittierCalifornia90602
Lucia Nguyen
[email protected]
562-698-0811
Lisa Wang (PRINCIPAL_INVESTIGATOR)
Southern Illinois Hospital ServicesCarbondaleIllinois62902
Sumita Kolay
[email protected]
Mohammad Popalzi (PRINCIPAL_INVESTIGATOR)
Cancer Care Specialist of IllinoisO'FallonIllinois62269
Kaitlynn Knapp
[email protected]
James Wade (PRINCIPAL_INVESTIGATOR)
Goshen Center for Cancer CareGoshenIndiana46526
James Wheeler (PRINCIPAL_INVESTIGATOR)
Trinity HealthAnn ArborMichigan48106
Christina Munson
[email protected]
Tareq Al baghdadi (PRINCIPAL_INVESTIGATOR)
Oncology Hematology AssociatesSpringfieldMissouri65807
Adrianna Moore
[email protected]
Roger Holden (PRINCIPAL_INVESTIGATOR)
Cancer Care Specialist of RenoRenoNevada89511
Layla Quinonez
[email protected]
Sowjanya Reganti (PRINCIPAL_INVESTIGATOR)
Summit Medical GroupFlorham ParkNew Jersey07932
Michelle Mackenzie
[email protected]
Steven Parish (PRINCIPAL_INVESTIGATOR)
Nashville GeneralNashvilleTennessee37208
Shatika Phillips
[email protected]
Robin Jacob (PRINCIPAL_INVESTIGATOR)
Cancer Care NorthwestSpokane ValleyWashington99216
Rachel Bender
[email protected]
Nikolas Rademaker (PRINCIPAL_INVESTIGATOR)
Gunderson HealthLa CrosseWisconsin54601
Charlie Abney
[email protected]
Paul Letendre (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Birmingham Hematology Associates· Birmingham, ALPIH Health Whittier Hospital· Whittier, CASouthern Illinois Hospital Services· Carbondale, ILCancer Care Specialist of Illinois· O'Fallon, ILGoshen Center for Cancer Care· Goshen, INTrinity Health· Ann Arbor, MI

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