Prediction of Appearance of Late Cutaneous Side Effects A... | NCT03060226

Studies
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

NCT03060226

Sponsor

Centre Francois Baclesse

Status

Completed

Last Update Posted

Dec 21, 2018Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Merkel Carcinoma
Radiotherapy Side Effect

Interventions

blood sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2017Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Dec 20, 2018Actual

First Submitted Date

Feb 14, 2017

First Submission Date that Met QC Criteria

Feb 17, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2018

Last Update Posted Date

Dec 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Other		Diagnostic Test: blood sample
radiosensibility group	Other		Diagnostic Test: blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Diagnostic Test	Search of blood predictive marker (s)	Control group radiosensibility group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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)	1 blood sample at inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre François Baclesse		France		14000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D011832	Radiation Injuries

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided