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NCT05433974 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05433974
Other study ID # APRI-Lux
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date June 1, 2024

Study information
Verified date June 2022
Source Centre Francois Baclesse, Luxembourg
Contact Guillaume Vogin, MD PhD
Phone 00352-2655661
Email guillaume.vogin@baclesse.lu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Blood sample collection
Blood sample collection : 2 X 6 mL

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Centre Francois Baclesse, Luxembourg BIONEXT, NEOLYS DIAGNOSTICS - ALARA GROUP

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of RadioDtect test on early radiation-induced toxicity 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 Validation of RadioDtect test on delayed radiation-induced toxicity 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
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