[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06789653":3,"trial-entities:NCT06789653":104,"trial-summary:NCT06789653":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":71,"locations":74,"central_contacts":93,"overall_officials":97,"references":99,"see_also_links":100},"NCT06789653","LCCC2435","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","RECRUITING","2027-11-01","2026-08","2026-08-18","2024-10-10","UNC Lineberger Comprehensive Cancer Center","OTHER",true,"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.\n\nPatients 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.\n\nDetermining 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.","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.\n\nRecent 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.\n\nPrevious 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.",[19],"Breast Cancer",[21,22,23,24,25,26,27],"proteomic","plasma proteomic","P16INK4A","chemotherapy","T cells","aging","morbidity","OBSERVATIONAL",null,[],{"count":32,"type":33},80,"ESTIMATED",[35,42],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DIAGNOSTIC_TEST","p16INK4a 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",[40,41],"Chemotherapy","Control",{"type":36,"name":43,"description":44,"armGroupLabels":45},"organ-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.",[40,41],[47,51],{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"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\u002FdL)",[],"FEMALE","22 Years","66 Years",false,{"inclusion":60,"exclusion":66,"raw_text":70},[61,62,63,64,65],"Age ≥22years and \\\u003C66 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.",[67,68,69],"Unable to provide consent, unable to communicate verbally.","Unable to understand or read English.","Enrolled in hospice care.","Inclusion Criteria:\n\n* Age ≥22years and \\\u003C66 years\n* Diagnosed with early-stage breast cancer (The American Joint Committee on Cancer stages I-III).\n* Understand and read English.\n* Receive care at the study site.\n* Able to understand and participate in study procedures for length of study.\n\nExclusion Criteria:\n\n* Unable to provide consent, unable to communicate verbally.\n* Unable to understand or read English.\n* Enrolled in hospice care.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":90},"University of North Carolina","Chapel Hill","North Carolina","27599","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Allison Rose","CONTACT","919-974-0000","allison_ross@med.unc.edu",{"name":88,"role":89},"Hyman Muss, MD","PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},35.9132,-79.05584,[94],{"name":95,"role":84,"phone":96,"email":86},"Allison Ross","919-966-3856",[98],{"name":88,"affiliation":13,"role":89},[],[101],{"label":102,"url":103},"Clinical trials at UNC Lineberger","http:\u002F\u002Funclineberger.org\u002Fpatientcare\u002Fclinical-trials\u002Fclinical-trials",{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to enroll 80 women.","completed","Observational Study on Organ Aging in Early-Stage Breast Cancer","This study is looking at how chemotherapy for early-stage breast cancer might affect aging in different organs. Researchers will collect blood samples from women with early-stage breast cancer before and after chemotherapy. They will measure levels of p16INK4a mRNA (a marker of cell aging) in T-cells and look for specific protein patterns in the blood that show how different organs are aging. The goal is to see if biological aging and accelerated immune system aging, measured in the blood, can tell us about aging in other organs. This could help identify patients at higher risk for side effects like heart problems or memory issues from chemotherapy. About 80 women are expected to join this study.","Your p16INK4a levels and organ-specific protein changes will be measured for up to 8 months.",115,"You would provide blood samples at two different times over a period of up to 8 months.","Not stated in the trial record.",[],"v2"]