NCT02517281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

July 12, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

February 7, 2014

Last Update Submit

March 19, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of clinical secondary effects bind to targeted therapies

    Dermatological exam including questionnaire, clinical examination and photographies

    Every 28 days up to 5 years

Study Arms (1)

Patients having received targeted therapies

EXPERIMENTAL

Patients treated using targeted therapies

Procedure: Biopsy

Interventions

BiopsyPROCEDURE
Patients having received targeted therapies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Caroline Robert, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

August 7, 2015

Study Start

July 12, 2011

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

FR(1)