Neoplasms PancreaticNCT05547074
A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma
An observational study of Neoplasms Pancreatic, run by Zhejiang University at 1 site in China.
Trial summary
The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms Pancreatic
- What is being tested?
- pancreatic cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: PDAC cases that underwent surgical resection (including radical or palliative surgery) from January 2016 to August 2019 were retrospectively reviewed and the survival follow-up (more than 14 months) was performed.
Who may be able to join
- Pathologically confirmed PDAC
- Achievement of surgical resection (including radical or palliative surgery)
Who cannot join
- Lost to follow-up
- Simultaneous presence of other tumors
- Died in three months after surgery
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Development and Validation of a New Prognostic Score Model Combining TNM Stage With Immune Risk Factors for Postoperative Pancreatic Ductal Adenocarcinoma
The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.
- Conditions
- Neoplasms Pancreatic
- Being tested
- pancreatic cancer surgery
- Keywords
- pancreatic ductal adenocarcinoma, prognostic model, tumor-infiltrating immune cell, staging
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic cancer surgeryProcedure or surgery
Surgical resection of pancreatic cancer，including radical or palliative surgery
| Study group | Role | What they receive |
|---|---|---|
| The training cohort | To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90). Receives: Procedure: pancreatic cancer surgery | |
| The validation cohort | To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90). Receives: Procedure: pancreatic cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
Measured: after pancreatic cancer surgery until october 31, 2020
Secondary outcomes (1)
disease-free survival disease-free survival disease-free survival disease-free survival
the number of months from the date of surgery to the date of first confirmable recurrence or death
Measured: after pancreatic cancer surgery until october 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Sep 2019
- Primary completion30 Oct 2020
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms PancreaticStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
- Investigators
- Tingbo Liang, Principal investigator, First Affiliated Hospital, Medical College of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547074
- Sponsor's protocol ID
- PSMPDAC
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Prognostic Score Model Combining TNM Stage With Immune Risk Factors for Postoperative Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05547074
- Acronym / sponsor ID
- PSMPDAC
- Conditions
- Neoplasms Pancreatic
- Keywords
- pancreatic ductal adenocarcinoma, prognostic model, tumor-infiltrating immune cell, staging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 21 Sep 2022 (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 AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The training cohort | – | Procedure: pancreatic cancer surgeryTo develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90). |
| The validation cohort | – | Procedure: pancreatic cancer surgeryTo develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- PDAC cases that underwent surgical resection (including radical or palliative surgery) from January 2016 to August 2019 were retrospectively reviewed and the survival follow-up (more than 14 months) was performed.
Key inclusion criteria (2 listed)
- Pathologically confirmed PDAC
- Achievement of surgical resection (including radical or palliative surgery)
Key exclusion criteria (3 listed)
- Lost to follow-up
- Simultaneous presence of other tumors
- Died in three months after 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 |
|---|---|---|
| pancreatic cancer surgerySurgical resection of pancreatic cancer，including radical or palliative surgery | Procedure or surgery | The training cohort, The validation cohort |
Primary outcome
overall survival
Time frame: after pancreatic cancer surgery until october 31, 2020
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
1 secondary outcome
disease-free survival disease-free survival disease-free survival disease-free survival
Time frame: after pancreatic cancer surgery until october 31, 2020
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 22 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
Tingbo Liang principal investigator
First Affiliated Hospital, Medical College of Zhejiang University
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 Neoplasms Pancreatic, run by Zhejiang 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 2 inclusion and 3 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 22 Sep 2022. 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?
overall survival (time frame: after pancreatic cancer surgery until october 31, 2020). 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 22 Sep 2022.