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COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Not Applicable
Completed
Conditions
Patients at Risk for Melanoma
Registration Number
NCT01610531
Lead Sponsor
Nantes University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4118
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Prevalence ratios between those of the COPARIME cohort and those of the general population.5 years

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

Secondary Outcome Measures
NameTimeMethod
Probability to develop a melanoma at one year.1 years
Cost ratio for a screened melanoma.5 years

Trial Locations

Locations (1)

University Hospital

🇫🇷

Nantes, France

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