Clinical trial NCT05926024: Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
Official title: Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Quality of life
Adverse Events
Cancer free
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 253
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women have been diagnosed with breast cancer and cancer-free for equal or more than 3 years.

Brief 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 criteria: Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Informed consent was obtained per Institutional Review Board guidelines to participate in the study and HIPAA authorization for the release of personal health information.
2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age ≥21 years at the time of consent.
4. Able to read and comprehend English.
5. No breast cancer recurrence or metastasis; no other cancer diagnosis other than basal cell or squamous cell cancers.

Exclusion Criteria:

1. Unable to read or comprehend English.
2. Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.

Primary outcomes:
measure: Change in Functional Well-being
timeFrame: At least 3 years after completion of chemotherapy
Secondary outcomes:
measure: Comparison of Functional well-being- Cohort B
timeFrame: At least 3 years after completion of chemotherapy
measure: Changes in self-reported cognition-Cohort A
timeFrame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
measure: Changes in self-reported cognition- Cohort B
timeFrame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
measure: Changes in self-reported peripheral neuropathy-Cohort A
timeFrame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
measure: Changes in self-reported peripheral neuropathy-Cohort B
timeFrame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
measure: Changes in self-reported Fatigue-Cohort A
timeFrame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
measure: Changes in self-reported Fatigue-Cohort B
timeFrame: Pre-chemotherapy and at least 3 years after completion of chemotherapy
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: