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

60 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

Inclusion Criteria5

  • 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 Criteria3

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

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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