Clinical trial · Observational
Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Recall Patient Reported Outcomes | Behavioral | — | UNRESOLVED |
| Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes | Behavioral | — | UNRESOLVED |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes | Behavioral | — | UNRESOLVED |
| Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes | Behavioral | — | UNRESOLVED |
| p16 tumor suppressor gene | Diagnostic Test | — | UNRESOLVED |
| Patient Reported Outcomes FACT-Endocrine Symptoms | Behavioral | — | UNRESOLVED |
| Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities.
- interventionNames
- Diagnostic Test: p16 tumor suppressor gene
- label
- Cohort B
- description
- 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.
- interventionNames
- Behavioral: Exercise Recall Patient Reported Outcomes
- Behavioral: Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes
- Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes
- Behavioral: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes
- Behavioral: Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)
- Behavioral: Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12)
- Behavioral: Patient Reported Outcomes PROMIS
- Behavioral: Patient Reported Outcomes FACT-Endocrine Symptoms
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available