A Novel Approach Utilizing Organ Specific Age Proteomics

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06789653
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 66 Years
Healthy Volunteers
Not accepted

Interventions

  • p16INK4a mRNA level assessment — DIAGNOSTIC_TEST
    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
  • organ-specific protein signatures assessment — DIAGNOSTIC_TEST
    Blood samples will be collected at two time points, plasma samples will be aliquoted, and organ-specific protein signatures assessment will be determined.

Study Details

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.

Key Dates

Start date
Oct 10, 2024
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Chemotherapy
    40 patients with early-stage breast cancer whose treatment plan includes adjuvant or neoadjuvant chemotherapy.
  • Arm: Control
    20 patients with early-stage breast cancer whose treatment plan does not includeadjuvant or neoadjuvant chemotherapy.

Primary Outcome Measure

p16INK4a level changes over time [ Time Frame: Up to 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599
Allison Rose
[email protected]
919-974-0000
Hyman Muss, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of North Carolina· Chapel Hill, NC

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