Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03956654
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2019-04-12
Brief Title:
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
Sponsor:
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
Blood samples will be collected at T0 ie at the time of inclusion of the patient at T1 ie at day 15 of the first treatment cycle and at T2 after 3 months and in addition to routine laboratory exams blood drawn will be processed and frozen for future translational research exploring biological aging markers as predictive markers of functional decline and survival and biomarkers of response prediction The central biobanking laboratory in Leuven will provide complete blood sampling sets per patient containing 3 subsets one for each time point with all blood tubes pre-printed labels and serumplasma aliquot vials required at that time point as well as disposable Pasteur pipettes for serumplasma transfer
Enrollment Count:
78
Enrollment Type:
ACTUAL
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 56182 |
Who Masked List: