PiA: Prognosis Used Every Day for Patients With Operable Breast Cancer - Comparison of Invasion Factors uPA/PAI-1 With Other Prognostic Factors
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Purpose
The improvement of the healing rates for breast cancer is based to an important part on the consistent use of so-called adjuvant ("supporting ") medicamentous therapies, including chemotherapy. However this success has a price due to still inaccurate knowledge of the individual risk of relapse: a high number of unnecessary therapies are applied (over-therapy!). The invasion factors uPA (plasminogen activator of the urokinase type) and PAI-1 (uPA inhibitor) were described extensively as strong and independent prognosis factors with high clinical relevance for patients with node negative breast cancer. Compared to clinical and pathological factors (further: "traditional factors ") they show better estimation of the relapse risk leading to an avoidance of redundant adjuvant chemotherapy and may thus essentially contribute to the improvement of the quality of life in these women. In this study we aim to evaluate, how large the portion of the patients with early, operable, node negative breast cancer will be, in whom, by improved low-risk identification through uPA/PAI-1, adjuvant chemotherapy can be omitted.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PiA Trial: a Cross-sectional, Multicenter, Consecutive Cohort Evaluating the Distribution of uPA/PAI-1 Versus St. Gallen Algorithm in >1000 Prospectively Included Patients |
- Event free survival [ Time Frame: 2.5 years minimum observation time ] [ Designated as safety issue: No ]All patients will be followed after a minimum observation time of 2.5 years.
- Overall survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]All patients will be followed after a minimum observation time of 2.5 years
Biospecimen Retention: Samples With DNA
Tumor specimen frozen Tumor specimen formalin fixed
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with newly diagnosed, operable breast cancer without metastasis.
Inclusion Criteria:
- newly diagnosed breast cancer
- no metastasis detected
- operation for breast cancer
- female patient
- unilateral breast cancer
- informed consent given
- age min. 18 yrs.
Exclusion Criteria:
- metastasis of breast cancer
- bilateral breast cancer
- other cancer within the last 5yrs
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eva Johanna Kantelhardt, Dr. med. E. Kantelhardt, Martin-Luther-Universität Halle-Wittenberg |
| ClinicalTrials.gov Identifier: | NCT01592825 History of Changes |
| Other Study ID Numbers: | GYN_Halle_01 |
| Study First Received: | May 3, 2012 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
|
Breast Cancer Prognostic factor uPA/PA-1 cohort |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013