NCT05433974

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

June 20, 2022

Last Update Submit

June 24, 2022

Conditions

RadiosensitivityCancerRadiation Toxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Validation of RadioDtect test on delayed radiation-induced toxicity

    12 months

Study Arms (1)

Radiosensitivity

OTHER

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

Interventions

Blood sample collectionBIOLOGICAL

Blood sample collection : 2 X 6 mL

Radiosensitivity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Guillaume Vogin, MD PhD

CONTACT

00352-2655661guillaume.vogin@baclesse.lu

Charlotte Lieunard

CONTACT

00352-5711-67421charlotte.lieunard@baclesse.lu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 27, 2022

Study Start

October 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

June 27, 2022

Record last verified: 2022-06