NCT02810093

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

June 20, 2016

Last Update Submit

June 20, 2016

Conditions

Keywords

Breast cancerText miningBig DataMachine Learning

Outcome Measures

Primary Outcomes (1)

  • Validate the reliability of a computer-based, automatic information retrieval method specific to medical records from breast cancer multidisciplinary meetings

    6 months

Secondary Outcomes (1)

  • Breast cancer recurrence rate after some therapeutic procedures

    6 months

Study Arms (1)

Breast cancer patients between 2000 and 2016

Patients treated for a breast cancer between 2000 and 2016 in the Hospital of Strasbourg (France).

Other: retrospective medical records analyze

Interventions

Ten thousand medical records (between years 2000 and 2016) will be analyzed

Breast cancer patients between 2000 and 2016

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients (men and women) suffering from an in situ or invasive cancer treated at Hôpitaux Universitaires de Strasbourg between years 2000 and 2016.

You may qualify if:

  • Majority (age \> 18)
  • Malignant breast tumors
  • signed informed consent

You may not qualify if:

  • Benign breast pathology
  • Patients not initially treated at the Hôpitaux Universitaires de Strasbourg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Strasbourg Hospital

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

  • Simoulin A, Thiebaut N, Neuberger K, Ibnouhsein I, Brunel N, Vine R, Bousquet N, Latapy J, Reix N, Moliere S, Lodi M, Mathelin C. From free-text electronic health records to structured cohorts: Onconum, an innovative methodology for real-world data mining in breast cancer. Comput Methods Programs Biomed. 2023 Oct;240:107693. doi: 10.1016/j.cmpb.2023.107693. Epub 2023 Jun 25.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carole Mathelin, MD

    Strasbourg's University Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations