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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

Sponsor
Centre Francois Baclesse, Luxembourg (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05433974
Collaborator
BIONEXT (Other), NEOLYS DIAGNOSTICS - ALARA GROUP (Other)
200
Enrollment
1
Arm
20
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood sample collection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Francois Baclesse, Luxembourg
  • BIONEXT
  • NEOLYS DIAGNOSTICS - ALARA GROUP

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Francois Baclesse, Luxembourg
ClinicalTrials.gov Identifier:
NCT05433974
Other Study ID Numbers:
  • APRI-Lux
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 27, 2022