Colorectal CancerPSN-AINCT06231524
Development and Validation of a PSN-AI Prediction Model
An observational study of Colorectal Cancer and Peritoneal Metastases, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Heterogeneity concerning survival in synchronous peritoneal metastasis from patients with colorectal cancer exists, thereby further classification is urgently required. This study aimed to validate a PSN-AI model based on DNA ploidy, stroma-tumor fraction, and nucleotyping (PSN) for the prediction of survival of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Peritoneal Metastases
- What is being tested?
- Analyse pathologic slides
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2025
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.
Who may be able to join
- Histological proof of synchronous peritoneal metastases of a nonappendiceal colorectal adenocarcinoma.
- Resectable disease determined by computed tomography (CT) and a peritoneal cancer index (PCI) of ≤20 at diagnostic laparoscopy or laparotomy;
- No evidence of systemic (e.g. liver, lung) colorectal metastases within three months prior to enrolment;
- Undergoing cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.
Who cannot join
- Combined with other types of malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qiyuan Qin, M.D., 86-20-38254052, qinqy3@mail.sysu.edu.cn
About this study
Official title: Development and Validation of a AI Prognostic Model Based on DNA Ploidy, Stroma, and Nucleotyping for Synchronous Peritoneal Metastasis From Colorectal Cancer
Heterogeneity concerning survival in synchronous peritoneal metastasis from patients with colorectal cancer exists, thereby further classification is urgently required. This study aimed to validate a PSN-AI model based on DNA ploidy, stroma-tumor fraction, and nucleotyping (PSN) for the prediction of survival of synchronous peritoneal metastasis from colorectal cancer.
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Being tested
- Analyse pathologic slides
- Keywords
- Colorectal Cancer, Synchronous peritoneal metastasis, DNA ploidy, Stroma-tumor fraction, Nucleotyping
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analyse pathologic slidesOther
HE-stained whole slide images were used for the validation of the PSN-AI model.
| Study group | Role | What they receive |
|---|---|---|
| Validation cohort | A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model validation. Receives: Other: Analyse pathologic slides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time between the date of diagnosis and the date of death (due to any cause) or the date of last follow-up.
Measured: At least 1-year follow up
Secondary outcomes (1)
Progression-free survival
The time from diagnosis to the onset of disease progression.
Measured: At least 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231524
- Sponsor's protocol ID
- PSN2023
- Acronym
- PSN-AI
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a AI Prognostic Model Based on DNA Ploidy, Stroma, and Nucleotyping for Synchronous Peritoneal Metastasis From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06231524
- Acronym / sponsor ID
- PSN-AI / PSN2023
- Conditions
- Colorectal Cancer, Peritoneal Metastases
- Keywords
- Colorectal Cancer, Synchronous peritoneal metastasis, DNA ploidy, Stroma-tumor fraction, Nucleotyping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 30 Jan 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.
Heterogeneity concerning survival in synchronous peritoneal metastasis from patients with colorectal cancer exists, thereby further classification is urgently required. This study aimed to validate a PSN-AI model based on DNA ploidy, stroma-tumor fraction, and nucleotyping (PSN) for the prediction of survival of synchronous peritoneal metastasis from colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation cohort | – | Other: Analyse pathologic slidesA cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model validation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.
Key inclusion criteria (4 listed)
- Histological proof of synchronous peritoneal metastases of a nonappendiceal colorectal adenocarcinoma.
- Resectable disease determined by computed tomography (CT) and a peritoneal cancer index (PCI) of ≤20 at diagnostic laparoscopy or laparotomy;
- No evidence of systemic (e.g. liver, lung) colorectal metastases within three months prior to enrolment;
- Undergoing cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.
Key exclusion criteria (1 listed)
- Combined with other types of malignant tumors.
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 |
|---|---|---|
| Analyse pathologic slidesHE-stained whole slide images were used for the validation of the PSN-AI model. | Other | Validation cohort |
Primary outcome
Overall survival
Time frame: At least 1-year follow up
The time between the date of diagnosis and the date of death (due to any cause) or the date of last follow-up.
1 secondary outcome
Progression-free survival
Time frame: At least 1-year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Colorectal Cancer and Peritoneal Metastases, run by Sixth Affiliated Hospital, Sun Yat-sen 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 4 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: status not confirmed, as of the sponsor's last update on 30 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiyuan Qin, PhD (+86-20-38254052, qinqy3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: At least 1-year follow up). 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 30 Jan 2024.