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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02893059
Other study ID # PHRC/2014/CC-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 2, 2016
Last updated September 7, 2016
Start date September 2017
Est. completion date September 2019

Study information

Verified date September 2016
Source Centre Hospitalier Universitaire de Nimes
Contact christel castelli, PhD
Email christel.castelli@chu-nimes.fr
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
Study type Observational

Clinical 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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date September 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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).

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).

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of data collected in a patient diary and data stored in the database of health insurance 6 month No