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NCT03060226 Clinical Trial

Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Radiotherapy Side Effect Clinical Trial

— PAESCART  

Official title:
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03060226
Other study ID # 2016-A02021-50
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2017
Est. completion date December 20, 2018

Study information
Verified date December 2018
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Search for blood predictive marker (s) for cutaneous radiosensitivity

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date December 20, 2018
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• blood sample
Search of blood predictive marker (s)

Locations
Country Name City State
France Centre François Baclesse France

Sponsors (1)
Lead Sponsor Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification and dosage of blood predictive marker(s) Concentration of IL-1a, IL-1ß, IL-4, IL-6, IL-8, IL-10, TNF-a, TGF-ß, IL-13, IL-17 and CRP 1 blood sample at inclusion
Primary Identification and dosage of blood predictive marker(s) Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase) 1 blood sample at inclusion
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