National Survey on Infiltrative Breast Cancer (CSI)

December 9, 2010 updated by: AstraZeneca

National Prospective Survey on Women With a Diagnosis of Infiltrative Breast Cancer

The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.

Study Overview

Status

Completed

Conditions

Infiltrative Breast Cancer

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix En Provence, France
    - Research Site
  - Aix En Provence Cedex 1, France
    - Research Site
  - Ales Cedex, France
    - Research Site
  - Amilly, France
    - Research Site
  - Angers Cedex 01, France
    - Research Site
  - Annecy, France
    - Research Site
  - Annecy Cedex, France
    - Research Site
  - Arpajon Cedex, France
    - Research Site
  - Arras, France
    - Research Site
  - Aubervilliers Cedex, France
    - Research Site
  - Aulnay Sous Bois Cedex, France
    - Research Site
  - Auxerre Cedex, France
    - Research Site
  - Avignon, France
    - Research Site
  - Avignon Cedex 2, France
    - Research Site
  - Beaune Cedex, France
    - Research Site
  - Besancon, France
    - Research Site
  - Beziers, France
    - Research Site
  - Bleriot, France
    - Research Site
  - Bordeaux, France
    - Research Site
  - Bordeaux Cedex, France
    - Research Site
  - Bourg En Bresse Cedex, France
    - Research Site
  - Brest Cedex 2, France
    - Research Site
  - Bruay La Buissiere Cedex, France
    - Research Site
  - Bruges Cedex, France
    - Research Site
  - Caen Cedex 4, France
    - Research Site
  - Caen Cedex 5, France
    - Research Site
  - Carcassonne, France
    - Research Site
  - Castelnau Le Lez Cedex, France
    - Research Site
  - Chalon Sur Saone, France
    - Research Site
  - Chambery, France
    - Research Site
  - Chambery Cedex, France
    - Research Site
  - Chartre, France
    - Research Site
  - Cherbourg Octeville Cedex, France
    - Research Site
  - Clermont Ferrand Cedex 1, France
    - Research Site
  - Colmar, France
    - Research Site
  - Colmar Cedex, France
    - Research Site
  - Colombes Cedex, France
    - Research Site
  - Coudekerque Branche Cedex, France
    - Research Site
  - Creteil Cedex, France
    - Research Site
  - Croix, France
    - Research Site
  - Cucq, France
    - Research Site
  - Dax Cedex, France
    - Research Site
  - Dijon Cedex, France
    - Research Site
  - Evreux, France
    - Research Site
  - Grasse Cedex, France
    - Research Site
  - Grenoble Cedex 2, France
    - Research Site
  - Guilherand Granges, France
    - Research Site
  - Hyeres, France
    - Research Site
  - La Chaussee St Victor, France
    - Research Site
  - La Garenne Colombes, France
    - Research Site
  - La Seyne Sur Mer, France
    - Research Site
  - La Tronche, France
    - Research Site
  - Lagny Sur Marne Cedex, France
    - Research Site
  - Le Chesnay Cedex, France
    - Research Site
  - Le Mans Cedex 2, France
    - Research Site
  - Lens Cedex, France
    - Research Site
  - Levallois Perret Cedex, France
    - Research Site
  - Libourne Cedex, France
    - Research Site
  - Lille, France
    - Research Site
  - Lille Cedex, France
    - Research Site
  - Limoges, France
    - Research Site
  - Limoges Cedex 1, France
    - Research Site
  - Loos, France
    - Research Site
  - Lorient Cedex, France
    - Research Site
  - Lormont, France
    - Research Site
  - Lyon, France
    - Research Site
  - Lyon Cedex 03, France
    - Research Site
  - Lyon Cedex 04, France
    - Research Site
  - Lyon Cedex 08, France
    - Research Site
  - Lyon Cedex 09, France
    - Research Site
  - Mantes La Jolie Cedex, France
    - Research Site
  - Mareuil Les Meaux, France
    - Research Site
  - Marseille, France
    - Research Site
  - Marseille Cedex 06, France
    - Research Site
  - Marseille Cedex 09, France
    - Research Site
  - Marseille Cedex 12, France
    - Research Site
  - Meudon La Foret, France
    - Research Site
  - Mont de Marsan Cedex, France
    - Research Site
  - Montmorency, France
    - Research Site
  - Montpellier, France
    - Research Site
  - Montpellier Cedex 5, France
    - Research Site
  - Mulhouse Cedex 1, France
    - Research Site
  - Nancy, France
    - Research Site
  - Nantes, France
    - Research Site
  - Neuilly Sur Seine, France
    - Research Site
  - Nice, France
    - Research Site
  - Nice Cedex 2, France
    - Research Site
  - Nimes, France
    - Research Site
  - Orleans Cedex 1, France
    - Research Site
  - Paris, France
    - Research Site
  - Paris Cedex 04, France
    - Research Site
  - Paris Cedex 05, France
    - Research Site
  - Paris Cedex 10, France
    - Research Site
  - Paris Cedex 15, France
    - Research Site
  - Paris Cedex 20, France
    - Research Site
  - Pessac, France
    - Research Site
  - Pierre Benite Cedex, France
    - Research Site
  - Ploemeur, France
    - Research Site
  - Poissy Cedex, France
    - Research Site
  - Quimper Cedex, France
    - Research Site
  - Reims, France
    - Research Site
  - Reims Cedex, France
    - Research Site
  - Rennes Cedex, France
    - Research Site
  - Roanne Cedex, France
    - Research Site
  - Rodez Cedex 9, France
    - Research Site
  - Rouen, France
    - Research Site
  - Rouen Cedex, France
    - Research Site
  - Saint Mandee, France
    - Research Site
  - Saintes Cedex, France
    - Research Site
  - Sarcelle, France
    - Research Site
  - Sarcelles, France
    - Research Site
  - St Benoit La Foret, France
    - Research Site
  - St Brieuc Cedex 1, France
    - Research Site
  - St Cloud, France
    - Research Site
  - St Herblain, France
    - Research Site
  - St Herblain Cedex, France
    - Research Site
  - St Jean, France
    - Research Site
  - St Martin Des Champs, France
    - Research Site
  - St Maur Des Fosses, France
    - Research Site
  - St Michel, France
    - Research Site
  - St Nazaire, France
    - Research Site
  - St Priest En Jarez Cedex, France
    - Research Site
  - Strasbourg, France
    - Research Site
  - TOURS cedex 2, France
    - Research Site
  - Thionville Cedex, France
    - Research Site
  - Toulon, France
    - Research Site
  - Toulon Cedex, France
    - Research Site
  - Toulouse, France
    - Research Site
  - Toulouse Cedex 3, France
    - Research Site
  - Tours Cedex 9, France
    - Research Site
  - Troyes Cedex, France
    - Research Site
  - Valence, France
    - Research Site
  - Valenciennes Cedex, France
    - Research Site
  - Vandoeuvre Les Nancy Cedex, France
    - Research Site
  - Vichy Cedex, France
    - Research Site
  - Villejuif Cedex, France
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

First ten consecutive women with infiltrative breast cancer seen by oncologists, and fulfilling eligibility criteria.

Description

Inclusion Criteria:

Women> or = 18 years old
Women with newly diagnosis of infiltrative breast cancer
Agree to take part in this study

Exclusion Criteria:

Women with other malignant tumor (except in situ cervical carcinoma or treated basal cell carcinoma)
Women with in situ ductal carcinoma or in situ lobular carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiological, Clinical and Histological characteristics Time Frame: Once	Once

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatments: Surgery, radiotherapy, chemotherapy, hormonotherapy. Time Frame: Once	Once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Alain Castaigne, Medical Director, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 12, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NIS-OFR-DUM-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.