Intraoperative Flow Cytometry In Colorectal Cancer
February 18, 2022 updated by: CHRISTINA BALI, University Hospital, Ioannina
Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Epirus
-
Ioannina, Epirus, Greece, 45500
- University Hospital of Ioannina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
biopsy proven colorectal cancer signed informed consent for participation
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
normal colorectal epithelium
Tissue samples from normal colorectal epithelium are collected during colectomy in every colorectal cancer patient
|
evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium
|
|
cancer colorectal epithelium
Tissue samples from colorectal cancer are collected during colectomy in every colorectal cancer patient
|
evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2017-2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2017
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
November 25, 2021
Study Registration Dates
First Submitted
February 6, 2022
First Submitted That Met QC Criteria
February 18, 2022
First Posted (Actual)
March 2, 2022
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 18, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27190/26-10-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.