Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Not Applicable

Completed

• Conditions: Radiotherapy Side Effect; Merkel Carcinoma
• Interventions: Diagnostic Test: blood sample

• Registration Number: NCT03060226
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

Search for blood predictive marker (s) for cutaneous radiosensitivity

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Status Verified: 2018-12
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-20
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiosensibility group	blood sample	-
Control group	blood sample	-

Primary Outcome Measures

Name	Time	Method
Identification and dosage of blood predictive marker(s)	1 blood sample at inclusion	Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase)

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 France, France