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Completed

NCT Number: NCT01610531

COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

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.

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Key information

Conditions

Patients at Risk for Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

SAMScore questionnaire

Other

Patients assessed at high risk according to the SAMScore

Primary outcomes

  1. 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

  1. Probability to develop a melanoma at one year.

    Time frame: 1 years

  2. Cost ratio for a screened melanoma.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2012
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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