Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

N/ACompletedNCT03060226

Centre Francois Baclesse18 enrolled

Overview

Search for blood predictive marker (s) for cutaneous radiosensitivity

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Merkel Carcinoma Radiotherapy Side Effect

Interventions

blood sampleDIAGNOSTIC_TEST

Search of blood predictive marker (s)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient treated with surgery and radiotherapy (RT) for histologically proven Merkel carcinoma * Previous radiotherapy treatment completed for at least 6 months * Absence of prior treatment by chemotherapy or hormonotherapy * Patient over 18 years of age * Patient affiliated to a social security system * Informed consent signed Exclusion Criteria: * Presence of another evolutionary cancer * Re-irradiation in the same area * Absence of available dosimetry data * Patient under guardianship or curatorship or safeguard of justice

Locations (1)

Centre François Baclesse

France, France

Outcomes

Primary Outcomes

Identification and dosage of blood predictive marker(s)

Concentration of IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α, TGF-β, IL-13, IL-17 and CRP

Time frame: 1 blood sample at inclusion

Identification and dosage of blood predictive marker(s)

Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase)

Time frame: 1 blood sample at inclusion

Data from ClinicalTrials.gov

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