Breast CancerNCT06789653
A Novel Approach Utilizing Organ Specific Age Proteomics
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 66 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- p16INK4a mRNA level assessment and organ-specific protein signatures assessment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 66 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Unable to provide consent, unable to communicate verbally.
- Unable to understand or read English.
- Enrolled in hospice care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Allison Rose, 919-974-0000, allison_ross@med.unc.edu
Hyman Muss, MD
About this study
Official title: Investigating Cellular Senescence and Organ Aging in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Novel Approach Utilizing Organ Specific Age Proteomics
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.
Read the detailed description
Chemotherapy has revolutionized cancer treatment, significantly improving relapse-free and survival rates for many cancers. However, these advances have come with a downside, and nowhere is this more evident than in childhood cancer. Despite the significant advances in the curability of most childhood cancers, up to 20% of patients die of comorbidity and secondary cancers by the age of 35 years.
Recent research shows that a plasma proteomic measure of protein abundance and expression can provide a" global" proteomic signature that accurately predicts chronologic age in the general population. It was shown that accelerated organ aging conferred a 20-50% higher mortality risk, and this was pronounced for those with accelerated cardiac and brain aging.
Previous studies have shown that p16INK4a, a robust biomarker of cell senescence measured in peripheral blood T cells, rises dramatically and likely irreversibly after adjuvant therapy for breast cancer. For anthracycline regimens, p16INK4a changes suggest 10 to 20 years of accelerated aging shortly after treatment. Additionally, in murine models, changes in P16INK4A are seen in all organs as mice age, but not all organs age at the same rate.
- Conditions
- Breast Cancer
- Being tested
- p16INK4a mRNA level assessment, organ-specific protein signatures assessment
- Keywords
- proteomic, plasma proteomic, P16INK4A, chemotherapy, T cells, aging, morbidity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p16INK4a mRNA level assessmentDiagnostic 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 assessmentDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Chemotherapy | 40 patients with early-stage breast cancer whose treatment plan includes adjuvant or neoadjuvant chemotherapy. Receives: 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. Receives: Diagnostic Test: p16INK4a mRNA level assessment; Diagnostic Test: organ-specific protein signatures assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start10 Oct 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789653
- Sponsor's protocol ID
- LCCC2435
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Cellular Senescence and Organ Aging in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Novel Approach Utilizing Organ Specific Age Proteomics
- ClinicalTrials.gov ID
- NCT06789653
- Acronym / sponsor ID
- LCCC2435
- Conditions
- Breast Cancer
- Keywords
- proteomic, plasma proteomic, P16INK4A, chemotherapy, T cells, aging, morbidity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chemotherapy has revolutionized cancer treatment, significantly improving relapse-free and survival rates for many cancers. However, these advances have come with a downside, and nowhere is this more evident than in childhood cancer. Despite the significant advances in the curability of most childhood cancers, up to 20% of patients die of comorbidity and secondary cancers by the age of 35 years.
Recent research shows that a plasma proteomic measure of protein abundance and expression can provide a" global" proteomic signature that accurately predicts chronologic age in the general population. It was shown that accelerated organ aging conferred a 20-50% higher mortality risk, and this was pronounced for those with accelerated cardiac and brain aging.
Previous studies have shown that p16INK4a, a robust biomarker of cell senescence measured in peripheral blood T cells, rises dramatically and likely irreversibly after adjuvant therapy for breast cancer. For anthracycline regimens, p16INK4a changes suggest 10 to 20 years of accelerated aging shortly after treatment. Additionally, in murine models, changes in P16INK4A are seen in all organs as mice age, but not all organs age at the same rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Diagnostic Test: p16INK4a mRNA level assessment, Diagnostic Test: organ-specific protein signatures assessment40 patients with early-stage breast cancer whose treatment plan includes adjuvant or neoadjuvant chemotherapy. |
| Control | – | Diagnostic Test: p16INK4a mRNA level assessment, Diagnostic Test: organ-specific protein signatures assessment20 patients with early-stage breast cancer whose treatment plan does not includeadjuvant or neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 22 to 66 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Unable to provide consent, unable to communicate verbally.
- Unable to understand or read English.
- Enrolled in hospice care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p16INK4a mRNA level assessmentBlood 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 test | Chemotherapy, Control |
| organ-specific protein signatures assessmentBlood samples will be collected at two time points, plasma samples will be aliquoted, and organ-specific protein signatures assessment will be determined. | Diagnostic test | Chemotherapy, Control |
Primary outcome
p16INK4a level changes over time
Time frame: Up to 8 months
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.
Organ-specific protein expression change over time
Time frame: Up to 8 months
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyman Muss, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Ross (919-966-3856, allison_ross@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
p16INK4a level changes over time (time frame: Up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.