Examining organ aging in breast cancer patients undergoing chemotherapy
Investigating Cellular Senescence and Organ Aging in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Novel Approach Utilizing Organ Specific Age Proteomics
This study is trying to see how chemotherapy affects the aging of organs in women with early-stage breast cancer to help identify those who might face more risks during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 22 Years to 66 Years |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06789653 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the changes in P16INK4A expression and plasma proteomic signatures in women with early-stage breast cancer before and after receiving adjuvant chemotherapy. It aims to assess whether biological and accelerated immune aging, evaluated through T cells from peripheral blood, reflects aging in various organs. By comparing baseline characteristics with organ aging, the study seeks to identify patients at higher risk for chemotherapy-related complications, particularly those receiving regimens that include anthracyclines and taxanes. The findings could inform treatment adjustments to mitigate risks associated with chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 22 to 65 diagnosed with early-stage breast cancer who are receiving adjuvant chemotherapy.
Not a fit: Patients who are unable to provide consent or are enrolled in hospice care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for chemotherapy complications, leading to tailored treatment strategies.
How similar studies have performed: Previous studies have indicated that proteomic measures can predict aging and associated risks, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Unable to provide consent, unable to communicate verbally. * Unable to understand or read English. * Enrolled in hospice care.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Hyman Muss, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Allison Ross
- Email: allison_ross@med.unc.edu
- Phone: 919-966-3856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.