Neoadjuvant Database (NEOADJ)

July 23, 2019 updated by: Centre Georges Francois Leclerc

Prospective and Retrospective Neoadjuvant Breast Cancer Database

The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way.

This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Contact

  • Name: AURELIE BERTAUT, MD, PhD
  • Phone Number: +33 3 80 73 77 84
  • Email: ABertaut@cgfl.fr

Study Locations

  • France
      • Dijon, France
        • Recruiting
        • Methodology, Biostatistics and Data Management Unit
        • Contact:
          • AURELIE BERTAUT

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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with non metastatic breast cancer who received neoadjuvant chemotherapy prior to tumor surgery.

Description

Inclusion Criteria:

  • Women followed for breast cancer in Georges Francois Leclerc Center
  • Neoadjuvant chemotherapy
  • Age >= 18

Exclusion Criteria:

  • Males
  • Metastatic breast cancer

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neoadjuvant Breast Cancer
Patients undergoing neoadjuvant therapy for breast cancer
Drug: Neoadjuvant therapy
Neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: 5 years
Overall survival and evolution over years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of patient and treatment characteristics
Time Frame: 5 years
Collection of patient and treatment characteristics over years, to set up prospective and retrospective studies
5 years

Collaborators and Investigators

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

Sponsor

Centre Georges Francois Leclerc

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 (Actual)

September 9, 2009

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB2009SEIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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