- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060226
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy (PAESCART)
December 20, 2018 updated by: Centre Francois Baclesse
Search for blood predictive marker (s) for cutaneous radiosensitivity
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
France, France, 14000
- Centre François Baclesse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group
|
Search of blood predictive marker (s)
|
Other: radiosensibility group
|
Search of blood predictive marker (s)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification and dosage of blood predictive marker(s)
Time Frame: 1 blood sample at inclusion
|
Concentration of IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α, TGF-β, IL-13, IL-17 and CRP
|
1 blood sample at inclusion
|
Identification and dosage of blood predictive marker(s)
Time Frame: 1 blood sample at inclusion
|
Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase)
|
1 blood sample at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2017
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
December 20, 2018
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
February 17, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
December 21, 2018
Last Update Submitted That Met QC Criteria
December 20, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2016-A02021-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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