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Validation of 70-gene MammaPrint Profile in Japanese Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904566
First Posted: May 19, 2009
Last Update Posted: June 23, 2015
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.
Collaborator:
Osaka General Medical Center
Information provided by (Responsible Party):
Agendia
  Purpose
By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis profile, MammaPrint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely be spared chemotherapy. The aim of this study is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with node-negative breast cancer.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation 70-gene MammaPrint Profile in Japanese Population

Resource links provided by NLM:


Further study details as provided by Agendia:

Primary Outcome Measures:
  • The probability of recurrence free survival (PRFS) [ Time Frame: 5 years ]

Enrollment: 102
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:
Frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70 years at diagnosis are hybridized on MammaPrint array. Patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between December 1998 and August 2001 at Osaka Medical Center for Cancer and Cardiovascular Diseases. Samples are evaluated by gene expression profiling for the 70-gene MammaPrint profile and classified as genomic high risk or genomic low risk.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients, node-negative, treated with breast conserving therapy or mastectomy with axilary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases.
Criteria

Inclusion Criteria:

  • Breast cancer patients
  • Node-negative
  • Treated with breast conserving therapy or mastectomy with axillary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases
  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): NCT00904566


Locations
Japan
Osaka Medical Center for Cancer and Cadiovascular Diseases
Osaka, Japan
Sponsors and Collaborators
Agendia
Osaka General Medical Center
Investigators
Study Chair: Kikuya Kato, MD, PhD, Prof Osaka Medical Center for Cancer and Cardiovascular Diseases
  More Information

Additional Information:
Responsible Party: Agendia
ClinicalTrials.gov Identifier: NCT00904566     History of Changes
Other Study ID Numbers: MP-107-RR
First Submitted: May 18, 2009
First Posted: May 19, 2009
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Agendia:
microarray
gene expression profiling
MammaPrint
breast cancer