NCT06231524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 4, 2024

Last Update Submit

January 26, 2024

Conditions

Colorectal CancerPeritoneal Metastases

Keywords

Colorectal CancerSynchronous peritoneal metastasisDNA ploidyStroma-tumor fractionNucleotyping

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Progression-free survival

    At least 1-year follow up

Study Arms (1)

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

Analyse pathologic slidesOTHER

HE-stained whole slide images were used for the validation of the PSN-AI model.

Validation cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Combined with other types of malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Primary tumor

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Qiyuan Qin, PhD

CONTACT

+86-20-38254052qinqy3@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 30, 2024

Study Start

February 1, 2024

Primary Completion

December 30, 2024

Study Completion

February 1, 2025

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

CN(1)