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COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01610531
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patients at Risk for Melanoma Other: SAMScore questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma
Actual Study Start Date : April 2011
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma


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


Primary Outcome Measures :
  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 Outcome Measures :
  1. Probability to develop a melanoma at one year. [ Time Frame: 1 years ]
  2. Cost ratio for a screened melanoma. [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610531


Locations
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France
University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Chair: Jean-Michel NGUYEN, Doctor Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01610531    
Other Study ID Numbers: BRD/10/11-N
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: May 2018
Keywords provided by Nantes University Hospital:
Cohort
Melanoma
targeted screening
risks function
cost effectiveness
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas