Metastatic Neuroendocrine TumourAURA-RIV-TNENCT06043193
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.
An observational study of Metastatic Neuroendocrine Tumour, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Neuroendocrine Tumour
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Feb 2024to 20 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 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
Who may be able to join
- 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;
Who cannot join
- Persons deprived of their liberty by a judicial or administrative decision;
- Adults subject to a legal protection measure (guardianship, curatorship);
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CH Métropole Savoie
Chambéry, 73000
Jean Cyril BOURRE, MD, 04 79 96 50 70, jean-cyril.bourre@ch-metropole-savoie.fr
Jean Cyril BOURRE, MD
- Recruiting
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand, 63011
Antony KELLY, MD, 04 73 27 80 80 ext. +33, antony.kelly@clermont.unicancer.fr
Antony KELLY, MD
- Recruiting
Hospices Civils de Lyon, Hopital Lyon Sud
Lyon, 69495
Nicolas JACQUET-FRANCILLON, MD, 4 72 35 69 99 ext. +33, nicolas.jacquet-francillon@chu-lyon.fr
- Recruiting
CHU de Saint-Etienne, Hôpital Nord
Saint-Priest-en-Jarez, Saint-Etienne, 42270
Vincent HABOUZIT, MD, 04 77 82 80 00 ext. +33, vincent.habouzit@chu-st-etienne.fr
Vincent HABOUZIT, MD
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.
Read more
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.
Read the 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 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.
- Conditions
- Metastatic Neuroendocrine Tumour
- Keywords
- IRV, Neuroendocrin, Quality of life
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Collection time: Week 0 (baseline) and 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: Time of collection: Week 0 (baseline), 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Feb 2024
- Primary completion20 Mar 2025
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Neuroendocrine TumourStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043193
- Sponsor's protocol ID
- 69HCL23_0367
- Other IDs
- 2023-A01344-41
- Acronym
- AURA-RIV-TNE
- Status last verified
- Jun 2025
- First submitted
- 10 Aug 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06043193
- Acronym / sponsor ID
- AURA-RIV-TNE / 69HCL23_0367
- Conditions
- Metastatic Neuroendocrine Tumour
- Keywords
- IRV, Neuroendocrin, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Persons deprived of their liberty by a judicial or administrative decision;
- Adults subject to a legal protection measure (guardianship, curatorship);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Analysis of quality of life at baseline (week 0)
Time frame: 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.
Time frame: Time of collection: Week 0 (baseline), 6 months and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Neuroendocrine Tumour, run by Hospices Civils de Lyon at 4 sites in France.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas JACQUET-FRANCILLON, MD (4 72 35 69 99 ext. +33, nicolas.jacquet-francillon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 11 Jun 2025.