Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC)NCT05441189
Precise Gene Signature for Predicting Outcomes in PDAC
An observational study of Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC) and Precise Prognostic and Predictive Signature, run by The Fourth Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
The current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC), Precise Prognostic and Predictive Signature
- What is being tested?
- Resection
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2021to 22 Jun 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The investigators enrolled two independent cohorts of consecutive patients with incident, primary, microscopically-confirmed stage I-II PDAC undergoing radical R0 resection only. For the training cohort, data were retrieved for 30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China. Patients who did not relapse or die within 1 year after resection had follow-up of at least 1 year. The investigators also included 40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga) as the validation cohort, with the same criteria as above; they were diagnosed between January 2010 and December 2013.
Who may be able to join
- Availability of hematoxylin and eosin slides with invasive tumor components
- Availability of clinicopathologic characteristics and follow-up data
- No previous history of cancer
Who cannot join
- No formalin-fixed, paraffin-embedded (FFPE) tumor sample of primary tumor
- Receipt of any neoadjuvant and/or adjuvant cancer-directed therapy
- Survival time <3 months after resection
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma
The current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. In this study, whole exosome sequencing was performed for patients with stage I-II PDAC undergoing R0 resection. The investigators aimed to identify genes with discrepant statuses of mutations or CNVs between patients with and without relapse within 1 year after R0 resection, and then to construct a support vector machine (SVM)-based prognostic classifier (the SVM signature) for PDAC using machine learning; the investigators then aimed to further validate the SVM signature in an independent cohort.
- Conditions
- Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC), Precise Prognostic and Predictive Signature
- Being tested
- Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResectionProcedure or surgery
radical R0 resection of pancreatic adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| training cohort | 30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China Receives: Procedure: Resection | |
| validation cohort | 40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga) Receives: Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
the time to recurrence at any site or all-cause death, whichever occurred first
Measured: 3-year
Overall survival
the time to death from any cause
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start19 Apr 2021
- Primary completion1 May 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Huang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441189
- Sponsor's protocol ID
- PaC-SVM1
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05441189
- Acronym / sponsor ID
- PaC-SVM1
- Conditions
- Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC), Precise Prognostic and Predictive Signature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 1 Jul 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 current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. In this study, whole exosome sequencing was performed for patients with stage I-II PDAC undergoing R0 resection. The investigators aimed to identify genes with discrepant statuses of mutations or CNVs between patients with and without relapse within 1 year after R0 resection, and then to construct a support vector machine (SVM)-based prognostic classifier (the SVM signature) for PDAC using machine learning; the investigators then aimed to further validate the SVM signature in an independent cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training cohort | – | Procedure: Resection30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China |
| validation cohort | – | Procedure: Resection40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators enrolled two independent cohorts of consecutive patients with incident, primary, microscopically-confirmed stage I-II PDAC undergoing radical R0 resection only. For the training cohort, data were retrieved for 30 patients undergoing resection between March 2015 and December 2016 at Chinese PLA General Hospital in Beijing, China. Patients who did not relapse or die within 1 year after resection had follow-up of at least 1 year. The investigators also included 40 patients from The Cancer Genome Atlas (TCGA) database (https://www.cancer.gov/about-nci/organization/ccg/research/structural-genomics/tcga) as the validation cohort, with the same criteria as above; they were diagnosed between January 2010 and December 2013.
Key inclusion criteria (3 listed)
- Availability of hematoxylin and eosin slides with invasive tumor components
- Availability of clinicopathologic characteristics and follow-up data
- No previous history of cancer
Key exclusion criteria (3 listed)
- No formalin-fixed, paraffin-embedded (FFPE) tumor sample of primary tumor
- Receipt of any neoadjuvant and/or adjuvant cancer-directed therapy
- Survival time <3 months after resection
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 |
|---|---|---|
| Resectionradical R0 resection of pancreatic adenocarcinoma | Procedure or surgery | training cohort, validation cohort |
Primary outcome
Disease-free survival
Time frame: 3-year
the time to recurrence at any site or all-cause death, whichever occurred first
Overall survival
Time frame: 3-year
the time to death from any cause
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 7 Jul 2022.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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 Stage I-II Pancreatic Ductal Adenocarcinoma (PDAC) and Precise Prognostic and Predictive Signature, run by The Fourth Affiliated Hospital of Anhui Medical 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 3 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 7 Jul 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?
Disease-free survival (time frame: 3-year). The study lists 2 primary outcomes in all. 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 7 Jul 2022.