Infiltrative Breast CancerCSINCT00696527
National Survey on Infiltrative Breast Cancer
An observational study of Infiltrative Breast Cancer, run by AstraZeneca at 107 sites in France.
Trial summary
The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infiltrative Breast Cancer
- How many people
- 1,500 participants
- Where
- 107 sitesFrance
- Study dates
- Jun 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: First ten consecutive women with infiltrative breast cancer seen by oncologists, and fulfilling eligibility criteria.
Who may be able to join
- Women> or = 18 years old
- Women with newly diagnosis of infiltrative breast cancer
- Agree to take part in this study
Who cannot join
- 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
Trial locations and contacts
107 sites in 1 country.
107 sites in 1 country
France107 sites
Research Site
Aix-en-Provence
Research Site
Alès
Research Site
Amilly
Research Site
Angers
Research Site
Annecy
Research Site
Arpajon
Research Site
Arras
Research Site
Aubervilliers
Research Site
Aulnay-sous-Bois
Research Site
Auxerre
Research Site
Avignon
Research Site
Beaune
Research Site
Besançon
Research Site
Béziers
Research Site
Bleriot
Research Site
Bordeaux
Research Site
Bourg-en-Bresse
Research Site
Brest
Research Site
Bruay-la-Buissière
Research Site
Bruges
Research Site
Caen
Research Site
Carcassonne
Research Site
Castelnau-le-Lez
Research Site
Chalon-sur-Saône
Research Site
Chambéry
Research Site
Chartre
Research Site
Cherbourg Octeville Cedex
Research Site
Clermont-Ferrand
Research Site
Colmar
Research Site
Colombes
Research Site
Coudekerque-Branche
Research Site
Créteil
Research Site
Croix
Research Site
Cucq
Research Site
Dax
Research Site
Dijon
Research Site
Évreux
Research Site
Grasse
Research Site
Grenoble
Research Site
Guilherand-Granges
Research Site
Hyères
Research Site
La Chaussée-Saint-Victor
Research Site
La Garenne-Colombes
Research Site
La Seyne-sur-Mer
Research Site
La Tronche
Research Site
Lagny-sur-Marne
Research Site
Le Chesnay
Research Site
Le Mans
Research Site
Lens
Research Site
Levallois-Perret
Research Site
Libourne
Research Site
Lille
Research Site
Limoges
Research Site
Loos
Research Site
Lorient
Research Site
Lormont
Research Site
Lyon
Research Site
Mantes-la-Jolie
Research Site
Mareuil-lès-Meaux
Research Site
Marseille
Research Site
Meudon-la-Forêt
Research Site
Mont-de-Marsan
Research Site
Montmorency
Research Site
Montpellier
Research Site
Mulhouse
Research Site
Nancy
Research Site
Nantes
Research Site
Neuilly-sur-Seine
Research Site
Nice
Research Site
Nîmes
Research Site
Orléans
Research Site
Paris
Research Site
Pessac
Research Site
Pierre-Bénite
Research Site
Ploemeur
Research Site
Poissy
Research Site
Quimper
Research Site
Reims
Research Site
Rennes
Research Site
Roanne
Research Site
Rodez
Research Site
Rouen
Research Site
Saint Mandee
Research Site
Saint-Benoît-la-Forêt
Research Site
Saint-Brieuc
Research Site
Saint-Cloud
Research Site
Saint-Herblain
Research Site
Saint-Martin-des-Champs
Research Site
Saint-Maur-des-Fossés
Research Site
Saint-Michel-sur-Orge
Research Site
Saint-Nazaire
Research Site
Saint-Priest-en-Jarez
Research Site
Saintes
Research Site
Sarcelle
Research Site
Sarcelles
Research Site
St.-Jean
Research Site
Strasbourg
Research Site
Thionville
Research Site
Toulon
Research Site
Toulouse
Research Site
Tours
Research Site
Troyes
Research Site
Valence
Research Site
Valenciennes
Research Site
Vandœuvre-lès-Nancy
Research Site
Vichy
Research Site
Villejuif
About this study
Official title: 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.
- Conditions
- Infiltrative Breast Cancer
- Keywords
- Infiltrative breast cancer-Clinical practice, Women with infiltrative breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological, Clinical and Histological characteristics
Measured: Once
Secondary outcomes (1)
Treatments: Surgery, radiotherapy, chemotherapy, hormonotherapy.
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infiltrative Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alain Castaigne, Medical Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696527
- Sponsor's protocol ID
- NIS-OFR-DUM-2007/1
- Acronym
- CSI
- Status last verified
- Dec 2010
- First submitted
- 10 Jun 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prospective Survey on Women With a Diagnosis of Infiltrative Breast Cancer
- ClinicalTrials.gov ID
- NCT00696527
- Acronym / sponsor ID
- CSI / NIS-OFR-DUM-2007/1
- Conditions
- Infiltrative Breast Cancer
- Keywords
- Infiltrative breast cancer-Clinical practice, Women with infiltrative breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First ten consecutive women with infiltrative breast cancer seen by oncologists, and fulfilling eligibility criteria.
Key inclusion criteria (3 listed)
- Women> or = 18 years old
- Women with newly diagnosis of infiltrative breast cancer
- Agree to take part in this study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiological, Clinical and Histological characteristics
Time frame: Once
1 secondary outcome
Treatments: Surgery, radiotherapy, chemotherapy, hormonotherapy.
Time frame: Once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Castaigne, Medical Director study director
AstraZeneca
107 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infiltrative Breast Cancer, run by AstraZeneca at 107 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological, Clinical and Histological characteristics (time frame: Once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.