Pregnant Women With a Breast Cancer Diagnosed Between 2000 and 2014

NCT ID: NCT01503034

Last Updated: 2018-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-14

Study Completion Date

2015-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Investigators will explain the purpose of the study to the eligible patients, still alive, and will inform them verbally and in writing, using the information note, of their possibility of refusal. No information will be made for deceased patients.

The investigators will complete the case report forms on paper and then will send them by mail.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study cohort

This cohort is made up of pregnant women with a breast cancer diagnosed between 2000 and 2014.

No interventions assigned to this group

Compared cohort

This cohort is made up of non-pregnant women with a breast cancer diagnosed between 2000 and 2009.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged 18 or over
* Confirmed histological diagnosis of invasive breast cancer
* No known metastasis
* For the cases :

* Patients pregnant at the time of the first diagnosis
* 1st diagnosis between 2000 and 2014
* For the controls :

* Patients not pregnant at the time of the first diagnosis
* 1st diagnosis between 2000 and 2009

Exclusion Criteria

* Patients who have undergone an induced abortion after the diagnosis of breast cancer
* Patients with a history of breast cancer
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurence VANLEMMENS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique Sainte Catherine

Avignon, , France

Site Status

Cabinet Dr Le Guen Naas

Baud, , France

Site Status

Centre Hospitalier Universitaire

Besançon, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

CHR

Brest, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Centre Hospitalier René Dubos

Cergy-Pontoise, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre Léonard de Vinci

Dechy, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre de Pharmacovigilance

Lille, , France

Site Status

Centre Hospitalier de Bretagne Sud

Lorient, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

CHRU La Peyronie et Centre Val d'Aurelle

Montpellier, , France

Site Status

Centre Catherine de Sienne

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Institut Curie

Paris, , France

Site Status

Hôpital Saint-Louis

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Polyclinique de Courlancy

Reims, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Clinique Radiologique

Saint-Brieuc, , France

Site Status

Centre René Huguenin

Saint-Cloud, , France

Site Status

Centre René Gauducheau

Saint-Herblain, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Institut Claudius Régaud

Toulouse, , France

Site Status

Cabinet Dr Leroy

Tourcoing, , France

Site Status

Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan

Tours, , France

Site Status

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cancer et grossesse

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.