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

Not Applicable

• Conditions: Cancer; Radiosensitivity; Radiation Toxicity
• Interventions: Biological: Blood sample collection

• Registration Number: NCT05433974
• Lead Sponsor: Centre Francois Baclesse, Luxembourg

Brief Summary

Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-24
• Last Update Submitted: 2022-06-24
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Study Start: 2022-10-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiosensitivity	Blood sample collection	Patient who agree to participate in this research study will have blood sample collected in order to perform the RadioDtect test.

Primary Outcome Measures

Name	Time	Method
Validation of RadioDtect test on early radiation-induced toxicity	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

Secondary Outcome Measures

Name	Time	Method
Validation of RadioDtect test on delayed radiation-induced toxicity	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