Case Report FormCORDNCT02893059
Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases
An observational study of Case Report Form and Declaration Bias, run by Centre Hospitalier Universitaire de Nīmes.
Trial summary
The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Case Report Form, Declaration Bias, Health Insurance Database
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to Sep 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of incident and prevalent cases of patients with chronic disease (diabetes, rheumatoid arthritis, chronic renal failure) or incident cases of prostate cancer, breast cance or colorectal cancer.
Who may be able to join
- incident and prevalent cases of patients with type I or type II diabetes. arthritis:
- incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010).
- Renal failure :
- incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not.
- Prostate cancer :
- Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy).
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- Breast cancer :
- Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast).
- Colorectal cancer :
- Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive).
Who cannot join
- The subject participates in an experimental study of research affecting the therapeutic management of the patient.
- The subject is exclusion period determined by a previous study.
- The subject is under judicial protection, guardianship or curatorship.
- It is not possible to give informed about information
- The subject does not read French and is not autonomous filling a questionnaire.
- The patient has psychiatric disorders.
- The subject is an emergency.
- Monitoring between patient visits than 6 months.
About this study
The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of data collected in a patient diary and data stored in the database of health insurance
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start1 Dec 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: the investigator has left the facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Case Report FormStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- christel castelli, PhD, Study director, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893059
- Sponsor's protocol ID
- PHRC/2014/CC-01
- Acronym
- CORD
- Status last verified
- Jun 2021
- First submitted
- 2 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases
- ClinicalTrials.gov ID
- NCT02893059
- Acronym / sponsor ID
- CORD / PHRC/2014/CC-01
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the investigator has left the facility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 8 Sep 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.
The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of incident and prevalent cases of patients with chronic disease (diabetes, rheumatoid arthritis, chronic renal failure) or incident cases of prostate cancer, breast cance or colorectal cancer.
Key inclusion criteria (10 listed)
- incident and prevalent cases of patients with type I or type II diabetes. arthritis:
- incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010).
- incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not.
- Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy).
- Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast).
Key exclusion criteria (8 listed)
- The subject participates in an experimental study of research affecting the therapeutic management of the patient.
- The subject is exclusion period determined by a previous study.
- The subject is under judicial protection, guardianship or curatorship.
- It is not possible to give informed about information
- The subject does not read French and is not autonomous filling a questionnaire.
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
comparison of data collected in a patient diary and data stored in the database of health insurance
Time frame: 6 month
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 18 Jun 2026.
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.
christel castelli, PhD study director
CHU Nimes
Questions about this trial
What is this clinical trial studying?
An observational study of Case Report Form and Declaration Bias, run by Centre Hospitalier Universitaire de Nīmes.
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 10 inclusion and 8 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
comparison of data collected in a patient diary and data stored in the database of health insurance (time frame: 6 month). 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 18 Jun 2026.