Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

NCT ID: NCT03060226

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-09

Study Completion Date

2018-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Search for blood predictive marker (s) for cutaneous radiosensitivity

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Merkel Carcinoma Radiotherapy Side Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Group Type OTHER

blood sample

Intervention Type DIAGNOSTIC_TEST

Search of blood predictive marker (s)

radiosensibility group

Group Type OTHER

blood sample

Intervention Type DIAGNOSTIC_TEST

Search of blood predictive marker (s)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sample

Search of blood predictive marker (s)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre François Baclesse

France, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A02021-50

Identifier Type: -

Identifier Source: org_study_id