Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hellenic Breast Surgeons Society |
---|---|
Information provided by: | Hellenic Breast Surgeons Society |
ClinicalTrials.gov Identifier: | NCT00814034 |
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.
Condition |
---|
Breast Cancer |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
Estimated Enrollment: | 238 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
1:Tamoxifen |
2:Steroidal Aromatase Inhibitor |
3:Non-steroidal Aromatase Inhibitor |
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).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Postmenopausal, ER and/or PgR positive breast cancer patients eligible for adjuvant hormonal treatment (HT), who are admitted for treatment and follow-up at the participating sites, will be enrolled in the trial. 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.
Inclusion Criteria:
Exclusion Criteria:
Contact: Christos Markopoulos, MD | +302107221413 | cmarkop@hol.gr |
Greece | |
Hellenic Breast Surgeons Society | Recruiting |
Athens, Greece, 11527 | |
Principal Investigator: Christos Markopoulos, MD |
Principal Investigator: | Christos Markopoulos, MD | Hellenic Breast Surgeons Society |
Responsible Party: | Hellenic Breast Surgeons Society ( Markopoulos Christos ) |
Study ID Numbers: | COPA-HBSS0801 |
Study First Received: | December 22, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00814034 |
Health Authority: | Greece: National Organization of Medicines |
Aromatase Inhibitors Coagulation parameters Tamoxifen |
Skin Diseases Breast Neoplasms Tamoxifen Breast Diseases |
Neoplasms Neoplasms by Site |