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OpenTrials
Completed

NCT Number: NCT03060226

Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Search for blood predictive marker (s) for cutaneous radiosensitivity

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Key information

Conditions

Merkel Carcinoma Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

France, 14000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Diagnostic Test

Search of blood predictive marker (s)

Primary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: PAESCART

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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