NCT03060226

Brief Summary

Search for blood predictive marker (s) for cutaneous radiosensitivity

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

February 14, 2017

Last Update Submit

December 20, 2018

Conditions

Merkel CarcinomaRadiotherapy Side Effect

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Control group

OTHER
Diagnostic Test: blood sample

radiosensibility group

OTHER
Diagnostic Test: blood sample

Interventions

blood sampleDIAGNOSTIC_TEST

Search of blood predictive marker (s)

Control groupradiosensibility group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

France, 14000, France

Location

MeSH Terms

Conditions

Radiation Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 23, 2017

Study Start

February 9, 2017

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)