NCT02530177
Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer
At risk: Primary completion moved at least 11 months later.
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Record History
All 21 versions: 12 with changes below, 9 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Notable Primary and study completion pushed from Aug 2026 to Aug 2027
- Eligibility criteria expanded, about 20 words
- Notable Primary and study completion dates: Aug 2024 to Aug 2026v18
- Notable Primary and study completion dates: Aug 2023 to Aug 2024v17
- Notable Primary and study completion dates: Aug 2021 to Aug 2023v14
- Minor Trial status: Recruiting to Active, Not Recruiting
- Enrollment target: 700 to 546
- Site details revised
Show 6 earlier versionsHide 6 earlier versions
- Notable Primary and study completion dates: Aug 2019 to Aug 2021v11
- Notable Primary and study completion dates: Aug 2018 to Aug 2019v10
- Notable Eligibility criteria expanded, about 18 words
- Study completion date: Aug 2018
- Start date: Aug 2015 to Aug 19, 2015
- Notable Eligibility criteria shortened, about 20 wordsv5
- Notable Eligibility criteria shortened, about 11 wordsv4
- Notable Eligibility criteria expanded, about 1 word
- Interventions: Clinical Assessments (Other), Questionnaires (Behavioral), Salvia sample (Other) to Clinical Assessments (Other), Questionnaires (Behavioral), Saliva sample (Other)
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Arms and interventions
Participants will undergo study related assessments and the appropriate HRQoL questionnaires will be administered. Baseline and follow-up clinical assessments will be performed, preferably when the patient presents to the clinic for (clinically indicated) standard-of-care visits. Initially, these visits will be coinciding with the appropriate chemotherapy dosing cycles (as applicable to select study cohorts), and subsequently they will be performed during the standard-of-care follow-up visits.
Participants will undergo study related assessments and Medical and Personal History Questionnaire data collection forms and the appropriate HRQoL questionnaires, will be administered. Baseline and follow-up clinical assessments will be performed, preferably when the patient presents to the clinic for standard-of-care visits. Initially, these visits will be coinciding with the appropriate therapy and subsequently they will be performed during the standard-of-care follow-up visits.
Menopausal women will include unrelated visitors accompanying breast cancer patients (e.g. friends) attending the breast medicine or dermatology clinics, or female employees of MSKCC. There will be no follow-up visits (after baseline) for participants in the comparator cohort.
Other: Clinical Assessments, Saliva sample
Behavioral: Questionnaires
Sites
1 site in 1 country
- Memorial Sloan Kettering Cancer CenterNew York, New York, United States