Intraoperative Flow Cytometry In Colorectal Cancer

Completed

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: flow cytometry

• Registration Number: NCT05261542
• Lead Sponsor: University Hospital, Ioannina

Brief Summary

This study was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.

Detailed Description

Tissue samples from normal and cancerous colon epithelium are collected intraoperatively following standard colectomy and analyzed blindly by flow cytometry, which reports, in less than 10 min, on the origin of the sample based in the estimation of DNA and tumor index.

Study Timeline

• Study Start: 2017-01-26
• Primary Completion: 2021-09-30
• Study Completion: 2021-11-25
• Status Verified: 2022-02
• Study First Submitted: 2022-02-06
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

biopsy proven colorectal cancer signed informed consent for participation

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cancer colorectal epithelium	flow cytometry	Tissue samples from colorectal cancer are collected during colectomy in every colorectal cancer patient
normal colorectal epithelium	flow cytometry	Tissue samples from normal colorectal epithelium are collected during colectomy in every colorectal cancer patient

Primary Outcome Measures

Name	Time	Method
Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer.	2017-2021	Samples from cancer and normal colon epithelium are prospectively collected intraoperatively and assessed with intraoperative Flow Cytometry. Following comparative DNA content and phenotypic analysis, the receiver operating characteristic (ROC) curve analysis is used to evaluate the performance of intraoperative Flow Cytometry to distinguish between normal and cancer tissue. The optimal cut-off value is determined to delineate the status of tumor tissue, resulting in the highest sensitivity and specificity and hence the optimal accuracy.

Trial Locations

Locations (1)

University Hospital of Ioannina; 🇬🇷 Ioannina, Epirus, Greece