Neuroendocrine TumorsFARINETNCT06356467
Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs
An observational study of Neuroendocrine Tumors and GEP-NET, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, GEP-NET
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2023to 31 Dec 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
- Adult, Older adult
Study population: Patients with well differentiated GEP-NENs
Who may be able to join
- Age >= 18
- Well-differentiated, localized (but not suitable for surgical treatment) or advanced (locally or with distant metastasis) GEP-NENs
- availability of data on site of primary tumor, stage of the, date of diagnosis
- treated with one (or more) of the following therapies:
- Somatostatin analogs
- G1 or G2 (Ki67 <10%) GEP-NENs
Show all 16Show fewer
- Treated for at least 6 months
- first-line therapy (or as second-line after surgery in patients with residual disease or recurrence after surgical resection)
- Sunitinib/Everolimus
- G1/G2 GEP-NENs
- Treated for at least 6 months
- first- or second-line therapy
- Capecitabine-Temozolomide (CAP-TEM)
- G2 or G3 (Ki67 < 55%) GEP-NENs
- first-, second-, or third-line therapy
- Treated for at least 6 months
Who cannot join
- Age < 18aa
- Patients concomitantly treated with loco-regional treatments
- Patients previously treated with radioligand therapy
- Patients with need of CAP-TEM dose reduction of more than 33% for at least 3 administrations
- NENs of unknown primitivity (including patients with biopsy on secondary lesion compatible with metastasis from GEP-NEN, but with occult primary neoplasm)
- Patients with Mixed NENs (MiNENs)
- Patients with poorly differentiated neuroendocrine carcinoma
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS OSpedale San Raffaele
Milan, 20132
Matteo Tacelli, PhD, 0226435507, tacelli.matteo@hsr.it
Laura Apadula, MSN, 0226433979, apadula.laura@hsr.it
About this study
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated.
Read the detailed description
This is an observational retrospective multicentric cohort study. The primary outcome of the study is the global Progression-free survival (PFS) adjusted for the risk factors considered. In a subgroup of patients only previously enrolled in San Raffaele Hospital that were included in the BIO-PANCREAS study (approval number INT/96/2021, a local monocentric protocol in which blood and/or Endoscopic UltraSound-Fine Needle Aspiration (EUS-FNA) derived samples are collected for further molecular analyses), the trascriptome signature will also be investigated as potential biomarker of disease behavior. Retrospective enrolment will be performed from January 2015 to March 2023. As for the primary aim, patients' and tumours' related variables will be investigated as explanatory variables for the outcome "time to progression", hence this analysis will allow a response to the clinical question of whether these factors have an influence on tumour behavior under treatment. As for the subgroup analysis (analysis of trascriptome signatures), again, this will be investigated to test whether there is a signature able to discriminate different responses to treatment.
- Conditions
- Neuroendocrine Tumors, GEP-NET
- Keywords
- GEP-NEN, NEN, GEP-NET
- Medical subject headings
- Neuroendocrine Tumors, Gastro-enteropancreatic neuroendocrine tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Progression Free Survival (PFS)
Global pfs adjusted for the risk factors considered
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start21 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Capurso, IRCCS San Raffaele
- Investigators
- Gabriele Capurso, PhD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356467
- Sponsor's protocol ID
- FARINET
- Acronym
- FARINET
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2024
- Last updated
- 15 Jan 2026
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs
- ClinicalTrials.gov ID
- NCT06356467
- Acronym / sponsor ID
- FARINET / FARINET
- Conditions
- Neuroendocrine Tumors, GEP-NET
- Keywords
- GEP-NEN, NEN, GEP-NET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2024 (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.
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated.
Detailed description
This is an observational retrospective multicentric cohort study. The primary outcome of the study is the global Progression-free survival (PFS) adjusted for the risk factors considered. In a subgroup of patients only previously enrolled in San Raffaele Hospital that were included in the BIO-PANCREAS study (approval number INT/96/2021, a local monocentric protocol in which blood and/or Endoscopic UltraSound-Fine Needle Aspiration (EUS-FNA) derived samples are collected for further molecular analyses), the trascriptome signature will also be investigated as potential biomarker of disease behavior. Retrospective enrolment will be performed from January 2015 to March 2023. As for the primary aim, patients' and tumours' related variables will be investigated as explanatory variables for the outcome "time to progression", hence this analysis will allow a response to the clinical question of whether these factors have an influence on tumour behavior under treatment. As for the subgroup analysis (analysis of trascriptome signatures), again, this will be investigated to test whether there is a signature able to discriminate different responses to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with well differentiated GEP-NENs
Key inclusion criteria (16 listed)
- Age >= 18
- Well-differentiated, localized (but not suitable for surgical treatment) or advanced (locally or with distant metastasis) GEP-NENs
- availability of data on site of primary tumor, stage of the, date of diagnosis
- treated with one (or more) of the following therapies:
Key exclusion criteria (8 listed)
- Age < 18aa
- Patients concomitantly treated with loco-regional treatments
- Patients previously treated with radioligand therapy
- Patients with need of CAP-TEM dose reduction of more than 33% for at least 3 administrations
- NENs of unknown primitivity (including patients with biopsy on secondary lesion compatible with metastasis from GEP-NEN, but with occult primary neoplasm)
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
Global Progression Free Survival (PFS)
Time frame: 6 months
Global pfs adjusted for the risk factors considered
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 15 Jan 2026.
- 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.
Gabriele Capurso, PhD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and GEP-NET, run by IRCCS San Raffaele at 1 site in Italy.
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 16 inclusion and 8 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Matteo Tacelli, PhD (0226435507, tacelli.matteo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Progression Free Survival (PFS) (time frame: 6 months). 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 15 Jan 2026.