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.
|
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.
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.