Multicenter Clinical StudyPred-InclusNCT03019068
Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From DRG Database
An observational study of Multicenter Clinical Study, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multicenter Clinical Study
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2024to Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Public institution-sponsored clinical studies.
Who may be able to join
- Multicenter trials.
- Trials that have been completed between 2012 and 2014.
- Sponsors and principal investigators of trials belonging to the public hospital system of the region of Paris (Ile de France).
Who cannot join
- Trials in the domain of rare diseases.
- Trials involving children.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Public Health - Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100
About this study
Official title: Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From the French DRG Database (PMSI)
This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate the potential recruitment of clinical trials centers.
Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against thorough examination of patient files.
Read more
Primary objective is to estimate the precision of the prediction system, i.e. ratio of numbers of eligible patient files / numbers of candidate patient files.
As secondary objectives, the study aims:
- to measure the recall rate or sensitivity of the system: ratio of number of candidates patient files / number of recruited patients;
- to measure the ability of coding: proportion of codable criteria (inclusion criteria or non inclusion criteria) into normalized language;
- to measure the time required for coding criteria and the time required to execute the queries on the national DRG database;
- to evaluate the reliability of coding process by an independent coding of a random sample of 30 protocols;
- to analyse influence of characteristics of the clinical study (design, disease, ...) and of the investigation site (volume, teaching status, ...) on the precision and sensitivity of the prediction system.
Read the detailed description
The study will be performed on a large sample (near 100) of multicenter terminated clinical studies with public funding covering therapeutic, diagnostic or prognostic studies. Selection (inclusion, non inclusion) criteria of each CT will be translated into a normalized description using ICD10 and french nomenclature of medical or surgical procedures (CCAM, Classification Commune des Actes Médicaux), these very nomenclatures being used in the french DRG system. Then a dedicated program will query the French DRG national database called PMSI (Programme de Médicalisation des Systèmes d'Information).
For each CT and for each center, the query will select "candidate" patients whose eligibility will be checked by thorough examination of the whole patient file by dedicated data extractors. In addition, already recruited patients will be compared to the prediction of the system.
Collected data span the period between 2010 and 2014, as well as with the medical files.
- Conditions
- Multicenter Clinical Study
- Keywords
- recruitment potential, prediction, databases, Clinical Trial Recruitment Support Systems (CTRSS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision
Precision = Ratio of number of eligible patient files / number of candidate patient files.
The precision will be calculated globally and according to medical domain and aim (therapeutic, diagnostic and prognostic) of modelized clinical studies.
Measured: throughout the study: 3 years
Secondary outcomes (1)
Sensitivity of system
Ratio of number of candidate patient files / number of already recruited patients.
Measured: throughout the study: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startApr 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The promotor decided to stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multicenter Clinical StudyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe AEGERTER, MD, PhD, Study chair, Department of Public Health - Hôpital Ambroise Paré (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019068
- Sponsor's protocol ID
- NI14011
- Other IDs
- PREPS-14-0607
- Acronym
- Pred-Inclus
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2017
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From the French DRG Database (PMSI)
- ClinicalTrials.gov ID
- NCT03019068
- Acronym / sponsor ID
- Pred-Inclus / NI14011
- Conditions
- Multicenter Clinical Study
- Keywords
- recruitment potential, prediction, databases, Clinical Trial Recruitment Support Systems (CTRSS)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The promotor decided to stopped.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jan 2017 (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.
This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate the potential recruitment of clinical trials centers.
Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against thorough examination of patient files.
Primary objective is to estimate the precision of the prediction system, i.e. ratio of numbers of eligible patient files / numbers of candidate patient files.
As secondary objectives, the study aims:
- to measure the recall rate or sensitivity of the system: ratio of number of candidates patient files / number of recruited patients;
- to measure the ability of coding: proportion of codable criteria (inclusion criteria or non inclusion criteria) into normalized language;
- to measure the time required for coding criteria and the time required to execute the queries on the national DRG database;
- to evaluate the reliability of coding process by an independent coding of a random sample of 30 protocols;
- to analyse influence of characteristics of the clinical study (design, disease, ...) and of the investigation site (volume, teaching status, ...) on the precision and sensitivity of the prediction system.
Detailed description
The study will be performed on a large sample (near 100) of multicenter terminated clinical studies with public funding covering therapeutic, diagnostic or prognostic studies. Selection (inclusion, non inclusion) criteria of each CT will be translated into a normalized description using ICD10 and french nomenclature of medical or surgical procedures (CCAM, Classification Commune des Actes Médicaux), these very nomenclatures being used in the french DRG system. Then a dedicated program will query the French DRG national database called PMSI (Programme de Médicalisation des Systèmes d'Information).
For each CT and for each center, the query will select "candidate" patients whose eligibility will be checked by thorough examination of the whole patient file by dedicated data extractors. In addition, already recruited patients will be compared to the prediction of the system.
Collected data span the period between 2010 and 2014, as well as with the medical files.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Public institution-sponsored clinical studies.
Key inclusion criteria (3 listed)
- Multicenter trials.
- Trials that have been completed between 2012 and 2014.
- Sponsors and principal investigators of trials belonging to the public hospital system of the region of Paris (Ile de France).
Key exclusion criteria (2 listed)
- Trials in the domain of rare diseases.
- Trials involving children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Precision
Time frame: throughout the study: 3 years
Precision = Ratio of number of eligible patient files / number of candidate patient files. The precision will be calculated globally and according to medical domain and aim (therapeutic, diagnostic and prognostic) of modelized clinical studies.
1 secondary outcome
Sensitivity of system
Time frame: throughout the study: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- 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.
Philippe AEGERTER, MD, PhD study chair
Department of Public Health - Hôpital Ambroise Paré (APHP)
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 Multicenter Clinical Study, run by Assistance Publique - Hôpitaux de Paris 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: withdrawn, as of the sponsor's last update on 20 Mar 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision (time frame: throughout the study: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.