Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06043193

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne, Hôpital Nord, Saint-Priest-en-Jarez, Saint-Etienne, France

Loading trial locations.

About this study

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.

The investigator 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Primary outcomes

  1. The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale

    Time frame: 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

Secondary outcomes

  1. Analysis of quality of life at baseline (week 0)

    Time frame: Collection time: Week 0 (baseline)

    Analysis of quality of life at baseline (Week 0) according to patient demographic profile and the characteristics of the tumour.

  2. Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion, during the treatment and at 12 months.

    Time frame: Time of collection: Week 0 (baseline), 6 months and 1 year

    .Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion (before the first cycle-IVR1), during IVR (IVR2 to IVRn), at 6 and 12 months after IVR1, will be assessed by 4 questionnaires (EORTC QLQ-C30 + EORTC QLQ-GI.NET21 + EQ-5D + HADS) forming a composite criterion.and response to treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline MANSUY

CONTACT

[email protected]

4 72 11 51 70 ext. +33

Nicolas JACQUET-FRANCILLON, MD

CONTACT

[email protected]

4 72 35 69 99 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: AURA-RIV-TNE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.