Back to resultsCOPARIME: Pilot Study of a Target Detection of Malignant Melanoma
Primary Purpose
Patients at Risk for Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SAMScore questionnaire
Sponsored by
About this trial
This is an interventional other trial for Patients at Risk for Melanoma focused on measuring Cohort, Melanoma, targeted screening, risks function, cost effectiveness
Eligibility Criteria
Inclusion Criteria:
- patients more than 18 years old,
- consulting their GP,
- assessed at risk for melanoma according to the SAMScore
- signed the consent.
Sites / Locations
- University Hospital
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Probability to develop a melanoma at one year.
Cost ratio for a screened melanoma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01610531
Brief Title
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma
Official Title
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients at Risk for Melanoma
Keywords
Cohort, Melanoma, targeted screening, risks function, cost effectiveness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4118 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
SAMScore questionnaire
Intervention Description
Patients assessed at high risk according to the SAMScore
Primary Outcome Measure Information:
Title
Prevalence ratios between those of the COPARIME cohort and those of the general population.
Description
Number of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Probability to develop a melanoma at one year.
Time Frame
1 years
Title
Cost ratio for a screened melanoma.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients more than 18 years old,
consulting their GP,
assessed at risk for melanoma according to the SAMScore
signed the consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel NGUYEN, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28982813
Citation
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.
Results Reference
derived
PubMed Identifier
26224016
Citation
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.
Results Reference
derived
PubMed Identifier
25141184
Citation
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.
Results Reference
derived
Learn more about this trial
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma
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