Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk

June 24, 2022 updated by: Centre Francois Baclesse, Luxembourg
Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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 over 18 years old
  • Patient with an indication for curative radiotherapy
  • Patient having given his signed written informed consent before any specific procedure of the protocol.

Exclusion Criteria:

  • Patient with a contraindication to radiotherapy
  • Patient with an indication for palliative radiotherapy
  • Patient with a history of radiotherapy in the area where the cancer is located
  • Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

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: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Radiosensitivity
Patient who agree to participate in this research study will have blood sample collected in order to perform the RadioDtect test.
Biological: Blood sample collection
Blood sample collection : 2 X 6 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of RadioDtect test on early radiation-induced toxicity
Time Frame: 3 months
prospectively validate the predictive capacities of the RadioDtect individual radiosensitivity blood test on early radiation-induced toxicity. The validation will be based on ATM protein assay and rate of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of RadioDtect test on delayed radiation-induced toxicity
Time Frame: 12 months
to prospectively validate the predictive capacities of the RadioDtect individual. radiosensitivity blood test on delayed radiation-induced toxicity at 12 months. The validation will be based on ATM protein assay and rate of acute toxicities of grade ≥ 2 to 3 months according to NCI-CTCAE v4.03 criteria
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse, Luxembourg

Collaborators

BIONEXT
NEOLYS DIAGNOSTICS - ALARA GROUP

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 (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2024

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (ACTUAL)

June 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • APRI-Lux

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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