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Observational Study on Organ Aging in Early-Stage Breast Cancer

This study is looking at how chemotherapy for early-stage breast cancer might affect aging in different organs. Researchers will collect blood samples from women with early-stage breast cancer before and after chemotherapy. They will measure levels of p16INK4a mRNA (a marker of cell aging) in T-cells and look for specific protein patterns in the blood that show how different organs are aging. The goal is to see if biological aging and accelerated immune system aging, measured in the blood, can tell us about aging in other organs. This could help identify patients at higher risk for side effects like heart problems or memory issues from chemotherapy. About 80 women are expected to join this study.

Study design
This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to enroll 80 women.
What's involved
You would provide blood samples at two different times over a period of up to 8 months.
Compensation
Not stated in the trial record.
Follow-up
Your p16INK4a levels and organ-specific protein changes will be measured for up to 8 months.

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NCT06789653

A Novel Approach Utilizing Organ Specific Age Proteomics

Recruiting
Not specifiedAges 22–66Observational
UNC Lineberger Comprehensive Cancer Center
~80 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:p16INK4a mRNA level assessmentorgan-specific protein signatures assessment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
p16INK4a level changes over time
Measured over Up to 8 months
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Hyman Muss, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Allison Ross
[email protected]
919-966-3856
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥22years and \<66 years
Diagnosed with early-stage breast cancer (The American Joint Committee on Cancer stages I-III).
Understand and read English.
Receive care at the study site.
Able to understand and participate in study procedures for length of study.

Exclusion

Unable to provide consent, unable to communicate verbally.
Unable to understand or read English.
Enrolled in hospice care.

What this trial measures

  • p16INK4a level changes over timeUp to 8 months

    The p16INK4a level will be determined from collected samples in each group. For the Chemotherapy Group, samples will be drawn before chemotherapy and 6-8 months after chemotherapy. For the Control Group, samples will be collected after diagnosis and again 6-8 months later. The differences will be tabulated.

  • Organ-specific protein expression change over timeUp to 8 months

    Organ-specific protein levels will be determined from collected samples in each group. For the Chemotherapy Group, samples will be drawn before chemotherapy and 6-8 months after chemotherapy. For the Control Group, samples will be collected after diagnosis and again 6-8 months later. The differences will be tabulated in grams per deciliter (g/dL)