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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05433974
Enrollment
200
Registered
2022-06-27
Start date
2022-10-01
Completion date
2024-06-01
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Radiation Toxicity, Radiosensitivity

Brief summary

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

Interventions

BIOLOGICALBlood sample collection

Blood sample collection : 2 X 6 mL

Sponsors

BIONEXT
CollaboratorUNKNOWN
Neolys
CollaboratorINDUSTRY
Centre Francois Baclesse, Luxembourg
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Validation of RadioDtect test on early radiation-induced toxicity3 monthsprospectively 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

MeasureTime frameDescription
Validation of RadioDtect test on delayed radiation-induced toxicity12 monthsto 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

Contacts

Primary ContactGuillaume Vogin, MD PhD
guillaume.vogin@baclesse.lu00352-2655661
Backup ContactCharlotte Lieunard
charlotte.lieunard@baclesse.lu00352-5711-67421

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026