Breast CancerSENOMETRYNCT02810093
Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis
An observational study of Breast Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- retrospective medical records analyze
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Dec 2016
- 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: Patients (men and women) suffering from an in situ or invasive cancer treated at Hôpitaux Universitaires de Strasbourg between years 2000 and 2016.
Who may be able to join
- Majority (age > 18)
- Malignant breast tumors
- signed informed consent
Who cannot join
- Benign breast pathology
- Patients not initially treated at the Hôpitaux Universitaires de Strasbourg
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Strasbourg Hospital
Strasbourg, 67091
Carole Mathelin, MD, 03 88 12 78 34, carole.mathelin.x@gmail.com
Karl Neuberger, kneuberger@quantmetry.com
About this study
Official title: SENOMETRY : Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis
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
- Conditions
- Breast Cancer
- Being tested
- retrospective medical records analyze
- Keywords
- Breast cancer, Text mining, Big Data, Machine Learning
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective medical records analyzeOther
Ten thousand medical records (between years 2000 and 2016) will be analyzed
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients between 2000 and 2016 | Patients treated for a breast cancer between 2000 and 2016 in the Hospital of Strasbourg (France). Receives: Other: retrospective medical records analyze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the reliability of a computer-based, automatic information retrieval method specific to medical records from breast cancer multidisciplinary meetings
Measured: 6 months
Secondary outcomes (1)
Breast cancer recurrence rate after some therapeutic procedures
Study of the recurrence rate of different subgroups of patients where various procedures were performed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Quantmetry
- Responsible party
- Sponsor
- Investigators
- Carole Mathelin, MD, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810093
- Sponsor's protocol ID
- 6373
- Acronym
- SENOMETRY
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37453367
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENOMETRY : Big Data and Text-mining Technologies Applied for Breast Cancer Medical Data Analysis
- ClinicalTrials.gov ID
- NCT02810093
- Acronym / sponsor ID
- SENOMETRY / 6373
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Text mining, Big Data, Machine Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Quantmetry
- Study start
- May 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Jun 2016 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients between 2000 and 2016 | – | Other: retrospective medical records analyzePatients treated for a breast cancer between 2000 and 2016 in the Hospital of Strasbourg (France). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Majority (age > 18)
- Malignant breast tumors
- signed informed consent
Key exclusion criteria (2 listed)
- Benign breast pathology
- Patients not initially treated at the Hôpitaux Universitaires de Strasbourg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective medical records analyzeTen thousand medical records (between years 2000 and 2016) will be analyzed | Other | Breast cancer patients between 2000 and 2016 |
Primary outcome
Validate the reliability of a computer-based, automatic information retrieval method specific to medical records from breast cancer multidisciplinary meetings
Time frame: 6 months
1 secondary outcome
Breast cancer recurrence rate after some therapeutic procedures
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Derived from this study: PubMed 37453367Simoulin 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.
- Individual participant dataSharing planned: No
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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.
Carole Mathelin, MD principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital, Strasbourg, France at 1 site 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: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Laudamy (+33 3 88 11 66 88, anne.laudamy@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the reliability of a computer-based, automatic information retrieval method specific to medical records from breast cancer multidisciplinary meetings (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810093, which also lists 1 linked publication.
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 22 Jun 2016.