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Recruiting Observational

Evaluation of the Quality of Life and Tolerance of Patients Treated With Vectorized Internal Radiotherapy (RIV) for a Neuro Endocrine Tumor (NET) in the Auvergne-Rhône-Alpes Region.

NCT06043193 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-02-20
Last updated
2025-06-11

Condition(s) studied

Metastatic Neuroendocrine Tumour

Study summary

The study consists of having participants complete quality of life questionnaires (PROMs) at the time of the cures +/- one week and in the middle of the intercure time +/- one week.

As all the collection times do not correspond to a consultation or a visit to a medical service, The investigator wanted to develop a remote, computerized data collection solution.

Researchers have programmed an AURA-RIV-TNE care pathway (MOCAs: Engine for the organization and coordination of health acts) on the myHCL patient environment, taking up the course of the study presented in the form of a table in paragraph 6.2. Once the patient consents to participate in the study, he must create an account on the patient interface of his investigation center (myHCL, myCHUGA etc) as much as possible to facilitate data extraction.

Once the patient consents to participate in the study, the MOCAs AURA-RIV-TNE course will be associated with him in the Easily software, by defining the date week 0 (baseline) of the first treatment. This will allow automated sending of MAIL and SMS reminders at each questionnaire time. The MAILs will contain an internet link allowing the participant to be directly written to the questionnaires to be completed. A reminder system will be possible if the patient does not complete the questionnaire.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \>18 years; * Patient starting treatment with RIV validated in the RENATEN RCP; * Patient having received written information about the study; * Collection of the patient's non-objection * Patients for whom treatment with RIV is administered within the framework of a clinical trial, may be included in the AURARIV-TNE study according to the written indications written in the 2 nd protocol of the sponsor of the clinical trial; * Patients undergoing re-treatment with RIV can be included; Exclusion Criteria: * Persons deprived of their liberty by a judicial or administrative decision; * Adults subject to a legal protection measure (guardianship, curatorship);

Primary outcome measure(s)

  • The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale — Collection time: Week 0 (baseline) and 1 year
    The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale. 10% missing data tolerable

Trial sites (4)

FacilityCityRegionStatus
CHU de Saint-Etienne, Hôpital Nord Saint-Priest-en-Jarez Saint-Etienne Recruiting
CH Métropole Savoie Chambéry France Recruiting
Centre de Lutte Contre le Cancer Jean Perrin Clermont-Ferrand France Recruiting
Hospices Civils de Lyon, Hopital Lyon Sud Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06043193 on ClinicalTrials.gov ↗ ← All trials in France