COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Patients at Risk for Melanoma Clinical Trial

Official title:

COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610531
• Other study ID #: BRD/10/11-N
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: February 2018

Study information

• Verified date: May 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4118
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients more than 18 years old,

• consulting their GP,

• assessed at risk for melanoma according to the SAMScore

• signed the consent.

Related Conditions & MeSH terms

• Melanoma
• Patients at Risk for Melanoma

Intervention

Other:
• SAMScore questionnaire
Patients assessed at high risk according to the SAMScore

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence ratios between those of the COPARIME cohort and those of the general population.	Number of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool.	5 years
Secondary	Probability to develop a melanoma at one year.		1 years
Secondary	Cost ratio for a screened melanoma.		5 years