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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
First received
Last updated
Start date December 1, 2020
Est. completion date September 2021

Study information

Verified date January 2019
Source Centre Hospitalier Universitaire de Nimes
Contact christel castelli, PhD
Phone +33466683403
Email christel.castelli@chu-nimes.fr
Is FDA regulated No
Health authority
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 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
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


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