Neuroendocrine NeoplasmTAPIOCANCT06343428
Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients
An observational study of Neuroendocrine Neoplasm, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Neoplasm
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2021to 19 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: NET G3 patients managed at IEO. Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. In case of "late-NET G3" a NEN-dedicated pathologist will perform a pathologic review of the previous NET G1/2, too, unless a NEN-dedicated pathologist has already done and except for diagnoses performed in a NEN-referral Center.
Who may be able to join
- Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. In case of "late-NET G3" (see Patients and Methods), a NEN-dedicated pathologist will perform a pathologic review of the previous NET G1/2, too, unless a NEN-dedicated pathologist has already done and except for diagnoses performed in a NEN-referral Center.
- Age > 18 years
- Signed written informed consent
- Available tumor tissue (formalin-fixed paraffin-embedded, FFPE) (preferably within 6 months). If the tumor contained in FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut. Preferably, 25 slides should be provided (minimum of 15 slides). If tumor tissue is not available, patients should be willing to undergone to a new biopsy.
- late-NET G3 patients that will come to our Institute at the moment of NET G3 diagnosis will be enrolled only if they performed 68 Gallium-DOTATOC positron emission tomography (PET)/CT and 18 fluorodeoxyglucose (FDG)-PET/CT for the previous NET G1/2. The previous functional imaging performed during the NET G1/2 history shall be available for the review by our specialist in nuclear medicine.
Who cannot join
- Diagnosis of well-differentiated NET G1/2 or poorly-differentiated NEC
- Diagnosis of mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) in which a NET G3 as neuroendocrine component
- Cytological diagnosis of NET G3 or not availability of tumor tissue for pathological analysis
- Concurrent neoplastic disease (e.g. advanced breast or prostatic cancer in hormonal treatment, hematologic diseases)
Trial locations and contacts
1 site in 1 country.
Cristina Mazzon contact
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Francesca Spada, MD
About this study
Official title: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients: an observAtional, Prospective Analysis of the Correlation Between Functional Imaging and Clinical Outcome (TAPIOCA)
The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.
The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).
However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed.
Read the detailed description
High-grade neuroendocrine neoplasms (NENs) represent the poorest prognosis category within NENs. During the years, the prognostic differences among the subgroups led to identify at least two subcategories of high-grade NENs, according the morphologic features of the two subtypes.
Indeed, the 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated NENs that called neuroendocrine tumors (NETs) G3 for pancreatic NENs and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs, allowing to separate NET G3 from the other high-grade, poorly-differentiated, NENs, so called neuroendocrine carcinomas (NECs).
However, since the new-category has been introduced, NET G3 category seemed to be more heterogeneous than presumed. Indeed, clinical, pathological and radiological features seemed to identify different prognostic subcategories of NET G3. We recently performed a retrospective analysis on a small pool of 48 NET G3 patients, correlating the clinical outcomes with these different features. The results of our study seemed to suggest prognostic and predictive factors that deserve to be prospectively explored to better understand this pathology and that might to be part of NET G3 multiparametric classification system. Based on the results of our retrospective analysis, we underlined the importance of a systematic and well-designed collection of high-quality data in order to improve our knowledge on this topic.
- Conditions
- Neuroendocrine Neoplasm
- Keywords
- High-grade neuroendocrine neoplasm, prognostic factor, predictive factor
- 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 |
|---|---|---|
| NET G3 patients | Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemical characteristics analysis
Analysis of the morphology Analysis of proliferation index Ki-67 Analysis of Ki-67 expression (as hotspot or a diffuse expression on the sample) Analysis of Synaptophysin, and chromogranin expression
Measured: 3 years
Secondary outcomes (1)
Review of the functional imaging
Analysis of homogeneity or inhomogeneity of radiotracer distribution Analysis of the concordance/discordance between functional imaging. For "late-NET G3", the specialist in nuclear medicine will review both functional imaging (before and after NET G3 diagnosis)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start19 Jul 2021
- Primary completion19 Jul 2024 (estimated)
- Study completion19 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Spada, MD, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343428
- Sponsor's protocol ID
- IEO 1519
- Acronym
- TAPIOCA
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 6 May 2024
- 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 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients: an observAtional, Prospective Analysis of the Correlation Between Functional Imaging and Clinical Outcome (TAPIOCA)
- ClinicalTrials.gov ID
- NCT06343428
- Acronym / sponsor ID
- TAPIOCA / IEO 1519
- Conditions
- Neuroendocrine Neoplasm
- Keywords
- High-grade neuroendocrine neoplasm, prognostic factor, predictive factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 19 Jul 2024 (estimated)
- Study completion
- 19 Jul 2026 (estimated)
- First posted
- 2 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.
The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.
The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).
However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed.
Detailed description
High-grade neuroendocrine neoplasms (NENs) represent the poorest prognosis category within NENs. During the years, the prognostic differences among the subgroups led to identify at least two subcategories of high-grade NENs, according the morphologic features of the two subtypes.
Indeed, the 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated NENs that called neuroendocrine tumors (NETs) G3 for pancreatic NENs and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs, allowing to separate NET G3 from the other high-grade, poorly-differentiated, NENs, so called neuroendocrine carcinomas (NECs).
However, since the new-category has been introduced, NET G3 category seemed to be more heterogeneous than presumed. Indeed, clinical, pathological and radiological features seemed to identify different prognostic subcategories of NET G3. We recently performed a retrospective analysis on a small pool of 48 NET G3 patients, correlating the clinical outcomes with these different features. The results of our study seemed to suggest prognostic and predictive factors that deserve to be prospectively explored to better understand this pathology and that might to be part of NET G3 multiparametric classification system. Based on the results of our retrospective analysis, we underlined the importance of a systematic and well-designed collection of high-quality data in order to improve our knowledge on this topic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NET G3 patients | – | –Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NET G3 patients managed at IEO. Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. In case of "late-NET G3" a NEN-dedicated pathologist will perform a pathologic review of the previous NET G1/2, too, unless a NEN-dedicated pathologist has already done and except for diagnoses performed in a NEN-referral Center.
Key inclusion criteria (5 listed)
- Histological diagnosis of well-differentiated neuroendocrine tumor G3 performed or reviewed by a NEN-dedicated pathologist. In case of "late-NET G3" (see Patients and Methods), a NEN-dedicated pathologist will perform a pathologic review of the previous NET G1/2, too, unless a NEN-dedicated pathologist has already done and except for diagnoses performed in a NEN-referral Center.
- Age > 18 years
- Signed written informed consent
- Available tumor tissue (formalin-fixed paraffin-embedded, FFPE) (preferably within 6 months). If the tumor contained in FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut. Preferably, 25 slides should be provided (minimum of 15 slides). If tumor tissue is not available, patients should be willing to undergone to a new biopsy.
- late-NET G3 patients that will come to our Institute at the moment of NET G3 diagnosis will be enrolled only if they performed 68 Gallium-DOTATOC positron emission tomography (PET)/CT and 18 fluorodeoxyglucose (FDG)-PET/CT for the previous NET G1/2. The previous functional imaging performed during the NET G1/2 history shall be available for the review by our specialist in nuclear medicine.
Key exclusion criteria (4 listed)
- Diagnosis of well-differentiated NET G1/2 or poorly-differentiated NEC
- Diagnosis of mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) in which a NET G3 as neuroendocrine component
- Cytological diagnosis of NET G3 or not availability of tumor tissue for pathological analysis
- Concurrent neoplastic disease (e.g. advanced breast or prostatic cancer in hormonal treatment, hematologic diseases)
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
Immunohistochemical characteristics analysis
Time frame: 3 years
Analysis of the morphology Analysis of proliferation index Ki-67 Analysis of Ki-67 expression (as hotspot or a diffuse expression on the sample) Analysis of Synaptophysin, and chromogranin expression
1 secondary outcome
Review of the functional imaging
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- 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. This study is not recruiting at the moment.
Cristina Mazzon contact
Francesca Spada, MD principal investigator
Istituto Europeo di Oncologia
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 Neoplasm, run by European Institute of Oncology 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Spada, MD (+390257489258, divisione.gastrointestinale@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemical characteristics analysis (time frame: 3 years). 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 6 May 2024.