RadiosensitivityNCT05433974
Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk
A study testing Blood sample collection in people with Radiosensitivity and Cancer, run by Centre Francois Baclesse, Luxembourg.
Trial summary
Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiosensitivity, Cancer, Radiation Toxicity
- What is being tested?
- Blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg
- Conditions
- Radiosensitivity, Cancer, Radiation Toxicity
- Being tested
- Blood sample collection
- Medical subject headings
- Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionBiological
Blood sample collection : 2 X 6 mL
| Study group | Role | What they receive |
|---|---|---|
| Radiosensitivity | Other | Patient who agree to participate in this research study will have blood sample collected in order to perform the RadioDtect test. Receives: Biological: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiosensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse, Luxembourg
- Sponsor type
- University, hospital or other
- Collaborators
- BIONEXT, Neolys
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433974
- Sponsor's protocol ID
- APRI-Lux
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-therapeutic Analysis of the Individual Radiosensitivity of Cancer Patients in Luxembourg (APRI-Lux): Prospective National Interventional Study With Minimal Risk
- ClinicalTrials.gov ID
- NCT05433974
- Acronym / sponsor ID
- APRI-Lux
- Conditions
- Radiosensitivity, Cancer, Radiation Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Francois Baclesse, LuxembourgUniversity, hospital or other
- Collaborators
- BIONEXT, Neolys
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-therapeutic analysis of the individual radiosensitivity of cancer patients in Luxembourg
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiosensitivity | Other | Biological: Blood sample collectionPatient who agree to participate in this research study will have blood sample collected in order to perform the RadioDtect test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood sample collection : 2 X 6 mL | Biological | Radiosensitivity |
Primary outcome
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
1 secondary outcome
Validation of RadioDtect test on delayed radiation-induced toxicity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection in people with Radiosensitivity and Cancer, run by Centre Francois Baclesse, Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Vogin, MD PhD (00352-2655661, guillaume.vogin@baclesse.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of RadioDtect test on early radiation-induced toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.