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COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01610531
Enrollment
4118
Registered
2012-06-04
Start date
2011-04-30
Completion date
2018-02-28
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients at Risk for Melanoma

Keywords

Cohort, Melanoma, targeted screening, risks function, cost effectiveness

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.

Interventions

OTHERSAMScore questionnaire

Patients assessed at high risk according to the SAMScore

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence ratios between those of the COPARIME cohort and those of the general population.5 yearsNumber of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool.

Secondary

MeasureTime frame
Probability to develop a melanoma at one year.1 years
Cost ratio for a screened melanoma.5 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026