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PiA: Prognosis Used Every Day for Patients With Operable Breast Cancer - Comparison of Invasion Factors uPA/PAI-1 With Other Prognostic Factors (PiA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592825
First Posted: May 7, 2012
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva Johanna Kantelhardt, Martin-Luther-Universität Halle-Wittenberg
  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

Resource links provided by NLM:


Further study details as provided by Eva Johanna Kantelhardt, Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 2.5 years minimum observation time ]
    All patients will be followed after a minimum observation time of 2.5 years.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2.5 years ]
    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: May 2021
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed, operable breast cancer without metastasis.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592825


Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Eva J Kantelhardt, MD Gynecology Martin Luther Univ Halle/Germany
  More Information

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
First Submitted: May 3, 2012
First Posted: May 7, 2012
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by Eva Johanna Kantelhardt, 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