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Clinical Trial NCT06043193 (AURA-RIV-TNE) for Metastatic Neuroendocrine Tumour is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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. (AURA-RIV-TNE) 100 Remote

Recruiting
Clinical Trial NCT06043193 (AURA-RIV-TNE) is an observational study for Metastatic Neuroendocrine Tumour that is recruiting. It started on 20 February 2024 with plans to enroll 100 participants. Led by Hospices Civils de Lyon, it is expected to complete by 20 September 2026. The latest data from ClinicalTrials.gov was last updated on 11 June 2025.
Brief 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 pathwa...

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Detailed Description
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 pathwa...

Show More
Official Title

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.

Conditions
Metastatic Neuroendocrine Tumour
Other Study IDs
  • AURA-RIV-TNE
  • 69HCL23_0367
  • 2023-A01344-41 (Other Identifier) (ID-RCB)
NCT ID Number
NCT06043193
Start Date (Actual)
2024-02-20
Last Update Posted
2025-06-11
Completion Date (Estimated)
2026-09-20
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Keywords
IRV, Neuroendocrin, Quality of life
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Major subjects, suffering from metastatic neuroendocrine tumours
Major subjects, suffering from metastatic neuroendocrine tumours, for whom the indication for treatment by vectorized internal radiotherapy is decided in a multidisciplinary consultation meeting (National Reference Network for the management of Neuro-Endocrine Tumors) and who will be treated in one of the 5 centers in the AURA region
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale
The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale. 10% missing data tolerable
Collection time: Week 0 (baseline) and 1 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Analysis of quality of life at baseline (week 0)
Analysis of quality of life at baseline (Week 0) according to patient demographic profile and the characteristics of the tumour.
Collection time: Week 0 (baseline)
Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion, during the treatment and at 12 months.
.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.
Time of collection: Week 0 (baseline), 6 months and 1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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;

  • Persons deprived of their liberty by a judicial or administrative decision;
  • Adults subject to a legal protection measure (guardianship, curatorship);
Hospices Civils de Lyon logoHospices Civils de Lyon
Study Central Contact
Contact: Nicolas JACQUET-FRANCILLON, MD, 4 72 35 69 99, [email protected]
Contact: Adeline MANSUY, 4 72 11 51 70, [email protected]
4 Study Locations in 1 Countries

Saint-Etienne

CHU de Saint-Etienne, Hôpital Nord, Saint-Priest-en-Jarez, Saint-Etienne, 42270, France
Vincent HABOUZIT, MD, Contact, 04 77 82 80 00, [email protected]
Vincent HABOUZIT, MD, Principal Investigator
Recruiting
CH Métropole Savoie, Chambéry, 73000, France
Jean Cyril BOURRE, MD, Contact, 04 79 96 50 70, [email protected]
Jean Cyril BOURRE, MD, Principal Investigator
Recruiting
Centre de Lutte Contre le Cancer Jean Perrin, Clermont-Ferrand, 63011, France
Antony KELLY, MD, Contact, 04 73 27 80 80, [email protected]
Antony KELLY, MD, Principal Investigator
Recruiting
Hospices Civils de Lyon, Hopital Lyon Sud, Lyon, 69495, France
Nicolas JACQUET-FRANCILLON, MD, Contact, 4 72 35 69 99, [email protected]
Recruiting