Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment

Status: Active_not_recruiting
Location: See location...
Intervention Type: Behavioral, Diagnostic test
Study Type: Observational
SUMMARY

This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life and function, 3 years or more after the treatment, in cancer-free subjects. There will be 2 groups. Cohort A: Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consent for this study activities. Cohort B: Women with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used. Furthermore, the long-term effects of treatment and a biomarker of aging cyclin-dependent kinase inhibitor 2A (CDKN2A,p16INK4a) and relation will be assessed.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
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⁃ In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

• Informed consent was obtained per Institutional Review Board guidelines to participate in the study and HIPAA authorization for the release of personal health information.

• Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.

• Age ≥21 years at the time of consent.

• Able to read and comprehend English.

• No breast cancer recurrence or metastasis; no other cancer diagnosis other than basal cell or squamous cell cancers.

Locations
United States
North Carolina
University of North Carolina
Chapel Hill
Time Frame
Start Date: 2023-01-06
Completion Date: 2028-01-31
Participants
Target number of participants: 253
Treatments
Cohort A
Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities.
Cohort B
Women with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used.
Sponsors
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov