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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02810093
Other study ID # 6373
Secondary ID
Status Recruiting
Phase N/A
First received June 20, 2016
Last updated June 20, 2016
Start date May 2016
Est. completion date December 2016

Study information

Verified date June 2016
Source University Hospital, Strasbourg, France
Contact Anne Laudamy
Phone +33 3 88 11 66 88
Email anne.laudamy@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Observational

Clinical Trial Summary

Primary purpose :

To develop a method to automatically extract and structure the information included in numerous medical records from breast cancer patients.

Secondary purpose :

With this procedure we can analyze the content of ten thousand anonymized textual medical records.

This information should enable us to explore many subjects, such as:

- The impact of certain therapeutic procedures

- The characteristics of sub-groups of patients

- Pregnancy associated breast cancers

- Risk factors


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Majority (age > 18)

- Malignant breast tumors

- signed informed consent

Exclusion Criteria:

- Benign breast pathology

- Patients not initially treated at the Hôpitaux Universitaires de Strasbourg

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
retrospective medical records analyze
Ten thousand medical records (between years 2000 and 2016) will be analyzed

Locations

Country Name City State
France University Strasbourg Hospital Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France Quantmetry

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validate the reliability of a computer-based, automatic information retrieval method specific to medical records from breast cancer multidisciplinary meetings 6 months No
Secondary Breast cancer recurrence rate after some therapeutic procedures Study of the recurrence rate of different subgroups of patients where various procedures were performed 6 months No
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