Study of Risk Factors and Clinical Characterization of Rapidly Growing Melanoma
2 other identifiers
observational
472
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedAugust 25, 2016
August 1, 2016
5.8 years
August 22, 2016
August 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Speed growth of melanoma size
1 year
Study Arms (1)
Patient with melanoma
Interventions
Eligibility Criteria
Breslow primitive melanoma \>1 mm patients
You may qualify if:
- Patient with Breslow primitive melanoma for over 1 mm skin affected
You may not qualify if:
- Patient unable to answer questionnair concerning its melanoma history desease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Study Officials
- STUDY DIRECTOR
Urielle DESALBRES
Assistance Publique Hopitaux De Marseille
- PRINCIPAL INVESTIGATOR
Caroline GAUDY, MD/PhD
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2016
First Posted
August 25, 2016
Study Start
August 1, 2010
Primary Completion
May 1, 2016
Study Completion
May 1, 2017
Last Updated
August 25, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share