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.

NCT ID: NCT06043193

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-20

Study Completion Date

2026-09-20

Brief Summary

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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

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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

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Metastatic Neuroendocrine Tumour

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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);
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Saint-Etienne, Hôpital Nord

Saint-Priest-en-Jarez, Saint-Etienne, France

Site Status RECRUITING

CH Métropole Savoie

Chambéry, , France

Site Status RECRUITING

Centre de Lutte Contre le Cancer Jean Perrin

Clermont-Ferrand, , France

Site Status RECRUITING

Hospices Civils de Lyon, Hopital Lyon Sud

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas JACQUET-FRANCILLON, MD

Role: CONTACT

4 72 35 69 99 ext. +33

Adeline MANSUY

Role: CONTACT

4 72 11 51 70 ext. +33

Facility Contacts

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Vincent HABOUZIT, MD

Role: primary

04 77 82 80 00 ext. +33

Jean Cyril BOURRE, MD

Role: primary

04 79 96 50 70

Antony KELLY, MD

Role: primary

04 73 27 80 80 ext. +33

Nicolas JACQUET-FRANCILLON, MD

Role: primary

4 72 35 69 99 ext. +33

Other Identifiers

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2023-A01344-41

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_0367

Identifier Type: -

Identifier Source: org_study_id

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