COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

NCT01610531 | Completed DMC

• 1 other identifier: BRD/10/11-N
• Study Type: interventional
• Target: 4,118
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients at Risk for Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  5 years

Secondary Outcomes (2)

• Probability to develop a melanoma at one year.

  1 years

• Cost ratio for a screened melanoma.

  5 years

Interventions

SAMScore questionnaire OTHER

Patients assessed at high risk according to the SAMScore

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, France

Location

Related Publications (3)

• Rat C, Hild S, Gaultier A, Khammari A, Bonnaud-Antignac A, Quereux G, Dreno B, Nguyen JM. Anxiety, locus of control and sociodemographic factors associated with adherence to an annual clinical skin monitoring: a cross-sectional survey among 1000 high-risk French patients involved in a pilot-targeted screening programme for melanoma. BMJ Open. 2017 Oct 5;7(10):e016071. doi: 10.1136/bmjopen-2017-016071.

  PMID: 28982813 DERIVED

• Rat C, Grimault C, Quereux G, Dagorne M, Gaultier A, Khammari A, Dreno B, Nguyen JM. Proposal for an annual skin examination by a general practitioner for patients at high risk for melanoma: a French cohort study. BMJ Open. 2015 Jul 29;5(7):e007471. doi: 10.1136/bmjopen-2014-007471.

  PMID: 26224016 DERIVED

• Rat C, Quereux G, Grimault C, Gaultier A, Khammari A, Dreno B, Nguyen JM. Melanoma incidence and patient compliance in a targeted melanoma screening intervention. One-year follow-up in a large French cohort of high-risk patients. Eur J Gen Pract. 2015 Jun;21(2):124-30. doi: 10.3109/13814788.2014.949669. Epub 2014 Aug 20.

  PMID: 25141184 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Michel NGUYEN, Doctor

  Nantes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: April 1, 2011
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-05

Locations

FR (1)