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Clinical Trials/NCT01610531
NCT01610531
Completed
Not Applicable

COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Nantes University Hospital1 site in 1 country4,118 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients at Risk for Melanoma
Sponsor
Nantes University Hospital
Enrollment
4118
Locations
1
Primary Endpoint
Prevalence ratios between those of the COPARIME cohort and those of the general population.
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
February 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients more than 18 years old,
  • consulting their GP,
  • assessed at risk for melanoma according to the SAMScore
  • signed the consent.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prevalence ratios between those of the COPARIME cohort and those of the general population.

Time Frame: 5 years

Number of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool.

Secondary Outcomes

  • Probability to develop a melanoma at one year.(1 years)
  • Cost ratio for a screened melanoma.(5 years)

Study Sites (1)

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