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CompletedNCT05261542Updated Mar 2, 2022

Intraoperative Flow Cytometry In Colorectal Cancer

An observational study in Colorectal Cancer, sponsored by University Hospital, Ioannina. Completed at 1 site in Greece. Open to participants aged 25 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by University Hospital, Ioannina · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
106
Ages
25 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 106 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital, Ioannina is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients diagnosed with colorectal cancer and being treated by standard colectomy or/and neoadjuvant theraphy according to current guidelines.

Inclusion criteria

biopsy proven colorectal cancer signed informed consent for participation

Exclusion criteria

Exclusion Criteria:

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
106 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • normal colorectal epithelium

    Tissue samples from normal colorectal epithelium are collected during colectomy in every colorectal cancer patient

    Diagnostic Test: flow cytometry

  • cancer colorectal epithelium

    Tissue samples from colorectal cancer are collected during colectomy in every colorectal cancer patient

    Diagnostic Test: flow cytometry

Interventions

  • Diagnostic testflow cytometry

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2017-2021

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Study locations

1 site
  • University Hospital of Ioannina
    Ioannina, Epirus 45500, Greece
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05261542
Lead sponsor
University Hospital, Ioannina
Responsible party
CHRISTINA BALI (ACCOSIATE PROFESOR OF SURGERY, University Hospital, Ioannina) — Principal investigator
First posted
Mar 2, 2022
Start date
Jan 26, 2017
Primary completion
Sep 30, 2021
Completion
Nov 25, 2021
Last update
Mar 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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