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Completed

NCT Number: NCT05261542

Intraoperative Flow Cytometry In Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

biopsy proven colorectal cancer signed informed consent for participation

Exclusion criteria

Treatment and study plan

Flow Cytometry

Diagnostic Test

evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium

Primary outcomes

  1. Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ioannina

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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