Pancreatic Neuroendocrine TumorsNCT07695532
A Clinical Risk Score to Stratify High-risk PanNETs
An observational study of Pancreatic Neuroendocrine Tumors, run by Fudan University at 1 site in China.
Trial summary
Considerable heterogeneity exists in the risk of recurrence after curative resection of pancreatic neuroendocrine tumors (PanNETs). Current clinicopathological parameters (e.g., grade, TNM stage) have limited capacity for individualized risk stratification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumors
- What is being tested?
- Curative surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 1 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1).
Who may be able to join
- Pathologically confirmed PanNETs; Underwent curative surgical resection (R0 or R1); Complete clinicopathological data (see detailed variable list); Complete postoperative follow-up data.
Who cannot join
- Received neoadjuvant therapy before surgery; Hereditary PanNETs or pancreatic neuroendocrine carcinoma (PNEC); Distant metastasis before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Clinically Applicable Risk Score for Identifying High-risk Pancreatic Neuroendocrine Tumors: Development, Validation, and Biological Correlates
Considerable heterogeneity exists in the risk of recurrence after curative resection of pancreatic neuroendocrine tumors (PanNETs). Current clinicopathological parameters (e.g., grade, TNM stage) have limited capacity for individualized risk stratification. There is an urgent need for a clinically accessible and operationally simple predictive tools to identify high-risk PanNETs for optimizing personalized postoperative treatment and follow-up strategies. This study aims to identify risk factors associated with recurrence of PanNETs and to develop a clinically applicable risk stratification tool based on multi-center cohorts and multi-omics validation for identifying high-risk patients.
Read the detailed description
To identify risk factors associated with recurrence after curative resection of PanNETs; To develop a predictive tool for recurrence of PanNETs based on routine clinicopathological features; To evaluate and validate the discriminative ability, calibration, and clinical benefit of the predictive tool; To perform biological validation of the predictive tool;
- Conditions
- Pancreatic Neuroendocrine Tumors
- Being tested
- Curative surgical resection
- Keywords
- Pancreatic Neuroendocrine Tumors, High-risk, recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative surgical resectionProcedure or surgery
After pathological confirmation of pancreatic neuroendocrine neoplasm, the patient underwent radical surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1) | Underwent curative surgical resection Receives: Procedure: Curative surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Time from surgery to first evidence of locoregional recurrence or distant metastasis confirmed by imaging or pathology
Measured: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.
Secondary outcomes (1)
Overall survival (OS)
Time from surgery to death from any cause. Patients alive at the time of last follow-up will be censored.
Measured: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jun 2017
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, IRCCS San Raffaele
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695532
- Sponsor's protocol ID
- CSPAC-NEN-6
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinically Applicable Risk Score for Identifying High-risk Pancreatic Neuroendocrine Tumors: Development, Validation, and Biological Correlates
- ClinicalTrials.gov ID
- NCT07695532
- Acronym / sponsor ID
- CSPAC-NEN-6
- Conditions
- Pancreatic Neuroendocrine Tumors
- Keywords
- Pancreatic Neuroendocrine Tumors, High-risk, recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- West China Hospital, IRCCS San Raffaele
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 10 Jul 2026 (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.
Considerable heterogeneity exists in the risk of recurrence after curative resection of pancreatic neuroendocrine tumors (PanNETs). Current clinicopathological parameters (e.g., grade, TNM stage) have limited capacity for individualized risk stratification. There is an urgent need for a clinically accessible and operationally simple predictive tools to identify high-risk PanNETs for optimizing personalized postoperative treatment and follow-up strategies. This study aims to identify risk factors associated with recurrence of PanNETs and to develop a clinically applicable risk stratification tool based on multi-center cohorts and multi-omics validation for identifying high-risk patients.
Detailed description
To identify risk factors associated with recurrence after curative resection of PanNETs; To develop a predictive tool for recurrence of PanNETs based on routine clinicopathological features; To evaluate and validate the discriminative ability, calibration, and clinical benefit of the predictive tool; To perform biological validation of the predictive tool;
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1) | – | Procedure: Curative surgical resectionUnderwent curative surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1).
Key inclusion criteria (1 listed)
- Pathologically confirmed PanNETs; Underwent curative surgical resection (R0 or R1); Complete clinicopathological data (see detailed variable list); Complete postoperative follow-up data.
Key exclusion criteria (1 listed)
- Received neoadjuvant therapy before surgery; Hereditary PanNETs or pancreatic neuroendocrine carcinoma (PNEC); Distant metastasis before surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curative surgical resectionAfter pathological confirmation of pancreatic neuroendocrine neoplasm, the patient underwent radical surgery. | Procedure or surgery | Patients with pathologically confirmed PanNETs who underwent curative surgical resection (R0/R1) |
Primary outcome
Recurrence-free survival (RFS)
Time frame: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.
Time from surgery to first evidence of locoregional recurrence or distant metastasis confirmed by imaging or pathology
1 secondary outcome
Overall survival (OS)
Time frame: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Neuroendocrine Tumors, run by Fudan University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jul 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: From baseline, follow-up visits were scheduled every 6 months for the first 5 years after surgery, and annually thereafter, up to 10 years (120 months) post-surgery.). 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 10 Jul 2026.