Development and Validation of a PSN-AI Prediction Model | NCT06231524

Studies
Development and Validation of a PSN-AI Prediction Model

NCT06231524

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jan 30, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Colorectal Cancer
Peritoneal Metastases

Interventions

Analyse pathologic slides

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Estimated

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Jan 4, 2024

First Submission Date that Met QC Criteria

Jan 26, 2024

First Posted Date

Jan 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2024

Last Update Posted Date

Jan 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 synchronous peritoneal metastasis from colorectal cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Validation cohort		A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model validation.	Other: Analyse pathologic slides

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Analyse pathologic slides	Other	HE-stained whole slide images were used for the validation of the PSN-AI model.	Validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	At least 1-year follow up

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	The time from diagnosis to the onset of disease progression.	At least 1-year follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Combined with other types of malignant tumors.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qiyuan Qin, PhD	Contact	+86-20-38254052		qinqy3@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sixth Affiliated Hospital, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided