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.
| NCT ID | NCT06043193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Metastatic Neuroendocrine Tumour |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2025-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-02-20 with a primary completion date of 2025-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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);
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06043193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Neuroendocrine Tumour. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06043193 currently recruiting?
Yes, NCT06043193 is actively recruiting participants. Contact the research team at nicolas.jacquet-francillon@chu-lyon.fr for enrollment information.
Where is the NCT06043193 trial being conducted?
This trial is being conducted at Saint-Priest-en-Jarez, France, Chambéry, France, Clermont-Ferrand, France, Lyon, France.
Who is sponsoring the NCT06043193 clinical trial?
NCT06043193 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 100 participants.