Study of Risk Factors and Clinical Characterization of Rapidly Growing Melanoma

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT02879474
Collaborator
(none)
472
1
81
5.8

Study Details

Study Description

Brief Summary

State of the question Over the past decade, the incidence of melanoma (MM) has steadily increased in France and in most developed countries. This increased incidence was concerned mainly MM thin while the incidence of MM thick that represent the true "killers", and mortality from MM remained stable or increased slightly over the same period. These epidemiological data and observations from everyday medical practice dermatologists suggest the existence of different growth patterns within MM. Indeed, some MM progressing slowly sometimes for decades before diagnosis but are thin at the time of resection. Conversely, others MM grow very quickly, resulting in thick tumors despite a diagnosis and resection sometimes very early. These fast growing MM (FGMM) probably contribute significantly to the relative mortality in MM, as improved screening failed to influence to this day.

Our team has already demonstrated that the growth kinetics of the MM was a prognostic factor of tumor aggressiveness regardless of the thickness of the tumor. Using the same method to calculate the growth rate, an Australian team recently studied the growth rate in a population of patients suffering from MM. In this population 1/3 of MM had a growth of more than 0.5 mm per month. Clinical aspects and FGMM of these risk factors were individuals (injuries symmetrical achromic and regular occurrence among about older and low-nevi). The European and Australian people are very different in particular regarding the prevention policy, these results can not be extrapolated to the French population.The main objective is to identify risk factors for FGMM in French propulation

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Melanoma scale questionnair

Study Design

Study Type:
Observational
Anticipated Enrollment :
472 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
May 1, 2016
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Patient with melanoma

Behavioral: Melanoma scale questionnair

Outcome Measures

Primary Outcome Measures

  1. Speed growth of melanoma size [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient with Breslow primitive melanoma for over 1 mm skin affected
Exclusion Criteria:
  • Patient unable to answer questionnair concerning its melanoma history desease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hopitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Assistance Publique Hopitaux De Marseille
  • Principal Investigator: Caroline GAUDY, MD/PhD, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02879474
Other Study ID Numbers:
  • AORC 2009
  • RC13_0082
First Posted:
Aug 25, 2016
Last Update Posted:
Aug 25, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2016