Study of Risk Factors and Clinical Characterization of Rapidly Growing Melanoma

Melanoma Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02879474
• Other study ID #: AORC 2009
• Secondary ID: RC13_0082
• Status: Active, not recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: August 22, 2016
• Start date: August 2010
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 472
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma
• Melanoma Cancer

Intervention

Behavioral:
• Melanoma scale questionnair

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed growth of melanoma size		1 year	No