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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02883933
Other study ID # 2015Ao006
Secondary ID
Status Completed
Phase N/A
First received August 25, 2016
Last updated August 25, 2016
Start date January 2004
Est. completion date December 2013

Study information

Verified date August 2016
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.


Description:

Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.


Recruitment information / eligibility

Status Completed
Enrollment 1548
Est. completion date December 2013
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with melanoma

- melanoma diagnosed between January 2004 and December 2011

- patients living in Champagne-Ardenne

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Data collection


Locations

Country Name City State
France Chu de Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Dabouz F, Barbe C, Lesage C, Le Clainche A, Arnoult G, Hibon E, Bernard P, Grange F. Clinical and histological features of head and neck melanoma: a population-based study in France. Br J Dermatol. 2015 Mar;172(3):707-15. doi: 10.1111/bjd.13489. Epub 2015 Feb 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Location of melanoma Location of melanoma was classified in head and neck (scalp, forehead, temples, ears, neck, eyelids, nose, cheeks and area around mouse/chin) or other location (upper limb, lower limb, trunk, hand and foot). Day 0 No
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