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COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

NCT ID: NCT01610531

Last Updated: 2018-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2018-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Patients at Risk for Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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SAMScore questionnaire

Patients assessed at high risk according to the SAMScore

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel NGUYEN, Doctor

Role: STUDY_CHAIR

Nantes University Hospital

Locations

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University Hospital

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 28982813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26224016 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25141184 (View on PubMed)

Other Identifiers

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BRD/10/11-N

Identifier Type: -

Identifier Source: org_study_id

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