Prospective Clinical and Biologic Study of Secondary Cutaneous Effects in Targeted Cancer Therapies

Not Applicable

• Conditions: Cancer
• Interventions: Procedure: Biopsy

• Registration Number: NCT02517281
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in patients treated using targeted therapies in order to have a better understanding of the skin pathophysiology.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Patients with cancer beginning a targeted therapy
• Patients able to follow the protocol
• Age >/= 18 years old
• Signed inform consent

Exclusion Criteria

• Patient unable to follow the protocol, having a non cooperative behavior or unable to come to follow up visits or unable to complete the study
• Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients having received targeted therapies	Biopsy	Patients treated using targeted therapies

Primary Outcome Measures

Name	Time	Method
Number of clinical secondary effects bind to targeted therapies	Every 28 days up to 5 years	Dermatological exam including questionnaire, clinical examination and photographies

Trial Locations

Locations (1)

Gustave Roussy Cancer Campus Grand Paris; 🇫🇷 Villejuif, Val De Marne, France