A Novel Approach Utilizing Organ Specific Age Proteomics

NCT06789653 | Recruiting DMC

• 1 other identifier: LCCC2435
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

proteomic; plasma proteomic; P16INK4A; chemotherapy; T cells; aging; morbidity

Outcome Measures

Primary Outcomes (2)

• p16INK4a level changes over time

  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.

  Up to 8 months

• Organ-specific protein expression change over time

  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)

  Up to 8 months

Study Arms (2)

Chemotherapy

40 patients with early-stage breast cancer whose treatment plan includes adjuvant or neoadjuvant chemotherapy.

Diagnostic Test: p16INK4a mRNA level assessment; Diagnostic Test: organ-specific protein signatures assessment

Control

20 patients with early-stage breast cancer whose treatment plan does not includeadjuvant or neoadjuvant chemotherapy.

Diagnostic Test: p16INK4a mRNA level assessment; Diagnostic Test: organ-specific protein signatures assessment

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

Chemotherapy; Control

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.

Chemotherapy; Control

Eligibility Criteria

• Age: 22 Years - 66 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast carcinoma were treated at the study site. Groups will be stratified to ensure that those receiving anthracycline-containing regimens are well-represented and into three different age groups: \< 50, 50 to 65, and 66 years and older

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• Clinical trials at UNC Lineberger

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected at two time points (pre-chemotherapy or shortly after breast cancer diagnosis if no chemotherapy is planned and then again 6-8 months later), plasma samples will be aliquoted and T cells will be separated and expression of p16INK4a mRNA in peripheral blood T-lymphocytes will be determined.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyman Muss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Ross

CONTACT

919-966-3856; allison_ross@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)