RecruitingNCT06789653

A Novel Approach Utilizing Organ Specific Age Proteomics

Investigating Cellular Senescence and Organ Aging in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Novel Approach Utilizing Organ Specific Age Proteomics


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

80 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer. It aims to determine if biological and accelerated immune aging, assessed using T cells from peripheral blood, represents aging in different organs. Patients receiving chemotherapy, especially adjuvant regimens that include anthracyclines and taxanes, often experience late development of cardiac toxicity, functional loss, and cognitive decline. Comparing baseline characteristics with organ aging before therapy might identify patients at the highest risk for chemotherapy complications. For example, this is clinically significant for patients whose therapy includes taxanes or other drugs known to cause peripheral neuropathy. Identifying aging in the neurological or vascular systems before treatment might lead to changes in regimens. Determining accelerated aging in specific organs allows for investigating interventions to mitigate organ damage. For instance, identifying patients at the highest risk of cardiac aging after treatment could lead to testing the effects of exercise, senolytics, and other strategies to reduce the risk of long-term heart disease.


Eligibility

Sex: FEMALEMin Age: 22 YearsMax Age: 66 Years

Plain Language Summary

Simplified for easier understanding

This study is using a new technique called organ-specific age proteomics — which measures proteins in the blood to estimate how biologically old different organs are — in women with early-stage breast cancer. The goal is to understand whether cancer treatment accelerates or affects the biological aging of specific organs. **You may be eligible if...** - You are between 22 and 65 years old - You have been diagnosed with early-stage breast cancer (stages I through III) - You can read and understand English - You receive care at the study site - You are able to follow the study procedures for the full study duration **You may NOT be eligible if...** - You are unable to give consent or communicate verbally - You cannot read or understand English - You are currently enrolled in hospice care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTp16INK4a mRNA level assessment

Blood samples will be collected at two time points, plasma samples will be aliquoted, and T cells will be separated and expression of p16INK4a mRNA in peripheral blood T-lymphocytes will be determined

DIAGNOSTIC_TESTorgan-specific protein signatures assessment

Blood samples will be collected at two time points, plasma samples will be aliquoted, and organ-specific protein signatures assessment will be determined.


Locations(1)

University of North Carolina

Chapel Hill, North Carolina, United States

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NCT06789653


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