Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-28 @ 7:10 PM
Study NCT ID:
NCT00814034
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2008-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy
Sponsor:
Hellenic Breast Surgeons Society
Organization:
Study Overview
Official Title:
An Observational, Prospective Cohort Study, on Blood Coagulation Parameters in Postmenopausal Patients With Operable Breast Cancer Who Are Treated as Per Standard Practice With Adjuvant Hormonal Therapy for a Total of 5 Years
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPA
Brief Summary:
The objective of the study is to monitor the changes of blood coagulation parameters in postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5 years. The values of the standard coagulation parameters throughout the study will be compared with the baseline values.
Detailed Description:
Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons. The choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy. Percentage change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of treatment. The blood coagulation parameters which will be measured are fibrinogen, prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: