Pancreatic CancerPaCNCT05589480
Machine Learning for Recurrence Risk of Pancreatic Cancer After Radical Resection
An observational study of Pancreatic Cancer, run by Luo Cong at 1 site in China.
Trial summary
Recurrence of Pancreatic Cancer(PCa) is a multifactorial event. Based on the clinicopathological characteristics and imaging data of patients with PCa, the investigators used image processing and machine learning algorithms to build a more comprehensive and robust model, and added some unused features to explore its… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- preoperative demographics, blood markers, surgical pathology information,and enhanced CT features.
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Sep 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: patients with PCa who underwent radical resection
Who may be able to join
- Have the results of enhanced CT examination of the pancreas within 1 month before surgery in our hospital;
- Radical resection of pancreatic cancer was performed in our hospital;
- There are follow-up results in our hospital, and the follow-up endpoints include disease recurrence or at least 12 months.
- Complete clinical medical records and imaging data.
Who cannot join
- non-R0 resection;
- Combined with other malignant tumors
- The patient's imaging data has technical problems or the lesion is too small (less than 1cm), which is not suitable for omics analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Data Prediction Based on Machine Learning for Recurrence Risk of Pancreatic Cancer After Radical Resection
Recurrence of Pancreatic Cancer(PCa) is a multifactorial event. Based on the clinicopathological characteristics and imaging data of patients with PCa, the investigators used image processing and machine learning algorithms to build a more comprehensive and robust model, and added some unused features to explore its clinical application value.
A retrospective analysis of patients with PCa who underwent radical resection at Zhejiang Cancer Hospital (Hangzhou, China) from January 2013 to December 2020. The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing radical PCa surgery in the investigators' hospital. The investigators used the PyRadiomics platform to extract image features.
- Conditions
- Pancreatic Cancer
- Being tested
- preoperative demographics, blood markers, surgical pathology information,and enhanced CT features.
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative demographics, blood markers, surgical pathology information,and enhanced CT features.Other
preoperative demographics, blood markers, surgical pathology information,and enhanced CT features.
| Study group | Role | What they receive |
|---|---|---|
| postoperative recurrence | Not described Receives: Other: preoperative demographics, blood markers, surgical pathology information,and enhanced CT features. | |
| postoperative non-recurrence | Not described Receives: Other: preoperative demographics, blood markers, surgical pathology information,and enhanced CT features. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Aug 2022
- Primary completion20 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luo Cong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luo Cong, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589480
- Sponsor's protocol ID
- Zhejiang CH
- Acronym
- PaC
- Status last verified
- Dec 2023
- First submitted
- 18 Oct 2022
- Last updated
- 11 Dec 2023
- Results posted
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Data Prediction Based on Machine Learning for Recurrence Risk of Pancreatic Cancer After Radical Resection
- ClinicalTrials.gov ID
- NCT05589480
- Acronym / sponsor ID
- PaC / Zhejiang CH
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Luo CongUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Oct 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.
Recurrence of Pancreatic Cancer(PCa) is a multifactorial event. Based on the clinicopathological characteristics and imaging data of patients with PCa, the investigators used image processing and machine learning algorithms to build a more comprehensive and robust model, and added some unused features to explore its clinical application value.
A retrospective analysis of patients with PCa who underwent radical resection at Zhejiang Cancer Hospital (Hangzhou, China) from January 2013 to December 2020. The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing radical PCa surgery in the investigators' hospital. The investigators used the PyRadiomics platform to extract image features.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative recurrence | – | Other: preoperative demographics, blood markers, surgical pathology information,and enhanced CT features. |
| postoperative non-recurrence | – | Other: preoperative demographics, blood markers, surgical pathology information,and enhanced CT features. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with PCa who underwent radical resection
Key inclusion criteria (4 listed)
- Have the results of enhanced CT examination of the pancreas within 1 month before surgery in our hospital;
- Radical resection of pancreatic cancer was performed in our hospital;
- There are follow-up results in our hospital, and the follow-up endpoints include disease recurrence or at least 12 months.
- Complete clinical medical records and imaging data.
Key exclusion criteria (3 listed)
- non-R0 resection;
- Combined with other malignant tumors
- The patient's imaging data has technical problems or the lesion is too small (less than 1cm), which is not suitable for omics analysis.
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 |
|---|---|---|
| preoperative demographics, blood markers, surgical pathology information,and enhanced CT features.preoperative demographics, blood markers, surgical pathology information,and enhanced CT features. | Other | postoperative non-recurrence, postoperative recurrence |
Primary outcome
Recurrence-free survival
Time frame: 1 year
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 11 Dec 2023.
- 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 Cancer, run by Luo Cong 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 4 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 11 Dec 2023. 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 (time frame: 1 year). 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 11 Dec 2023.