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NCT05261542 Clinical Trial

Intraoperative Flow Cytometry In Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:
Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05261542
Other study ID # 27190/26-10-2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 26, 2017
Est. completion date November 25, 2021

Study information
Verified date February 2022
Source University Hospital, Ioannina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date November 25, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 90 Years
Eligibility Inclusion Criteria: biopsy proven colorectal cancer signed informed consent for participation Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• flow cytometry
evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium

Locations
Country Name City State
Greece University Hospital of Ioannina Ioannina Epirus

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer. 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. 2017-2021
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