Intraoperative Flow Cytometry In Colorectal Cancer
Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry
1 other identifier
observational
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedFirst Submitted
Initial submission to the registry
February 6, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedMarch 2, 2022
February 1, 2022
4.7 years
February 6, 2022
February 18, 2022
Conditions
Outcome Measures
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.
2017-2021
Study Arms (2)
normal colorectal epithelium
Tissue samples from normal colorectal epithelium are collected during colectomy in every colorectal cancer patient
cancer colorectal epithelium
Tissue samples from colorectal cancer are collected during colectomy in every colorectal cancer patient
Interventions
evaluation of intraoperative flow cytometry in detecting cancer cells in colorectal epithelium
Eligibility Criteria
patients diagnosed with colorectal cancer and being treated by standard colectomy or/and neoadjuvant theraphy according to current guidelines.
You may qualify if:
- biopsy proven colorectal cancer signed informed consent for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Ioannina
Ioannina, Epirus, 45500, Greece
Biospecimen
tissue samples from normal and cancer epithelium collected following colectomy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ACCOSIATE PROFESOR OF SURGERY
Study Record Dates
First Submitted
February 6, 2022
First Posted
March 2, 2022
Study Start
January 26, 2017
Primary Completion
September 30, 2021
Study Completion
November 25, 2021
Last Updated
March 2, 2022
Record last verified: 2022-02