IBIS-II-O: Observational long-term follow up study of participants from the IBIS-II DCIS and Prevention clinical trials of drugs for breast cancer preventio
Not Applicable
- Conditions
- Breast cancer preventionCancer
- Registration Number
- ISRCTN17443780
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 3000
Inclusion Criteria
1. Randomised to treatment in IBIS- II Prevention or DCIS studies
2. Participant was known to be alive at the point the study closed
3. Has given valid consent to participate in compliance with local and national requirements
4. Participant’s local IBIS-II study site is closed to the IBIS-II Prevention and DCIS CTIMP study protocols
Exclusion Criteria
1. Participant death has been reported to the study during their participation in the IBIS-II Prevention and DCIS CTIMP study
2. Participant has withdrawn consent to participate in IBIS-II Prevention and DCIS CTIMP studies
3. Participant has withdrawn consent to digital registry flagging in the IBIS-II Prevention and DCIS CTIMP study
4. Participant known to have emigrated
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured at the end of the study:<br>1. IBIS-II Prevention cohort: incidence of breast cancer measured via data from the digital registry or local pathology report with histologically confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS) when registry data is not sufficient<br>2. IBIS-II DCIS cohort: incidence of breast cancer measured using data from digital registry or local pathology report with histologically confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS) when registry data is not sufficient.
- Secondary Outcome Measures
Name Time Method Measured at the end of the study:<br>1. IBIS-II Prevention Cohort: breast cancer mortality<br>2. IBIS-II DCIS Cohort: breast cancer mortality<br>Both measured via COD and date confirmed via data registry