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Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients

Primary Purpose

Colorectal Cancer, Circulating Tumor Cell

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
CTC/DTC count
Sponsored by
The Institute of Molecular and Translational Medicine, Czech Republic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Prognostic significance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- colorectal adenocarcinoma

Exclusion Criteria:

  • prior neoadjuvant chemoradiotherapy
  • prior colorectal cancer
  • cancer duplicity

Sites / Locations

  • University Hospital Olomouc

Outcomes

Primary Outcome Measures

CEA mRNA positive circulating tumor cells in colorectal cancer patients
The absolute gene expression of carcinoembryonic antigen (CEA mRNA) in circulating tumor cells (CTCs) purified from peripheral blood of patients before colorectal surgery will be measured using real-time RT-PCR method. The CEA gene expression will be normalized per microgram of total mRNA. The cut-off values identifying presence or absence of CEA mRNA positive CTCs in patients was established using the maxstat() function from the maxstat R package as a mode value of estimates obtained for 10 000 random samples. CEA mRNA levels above 190 CEA mRNA copies per microgram of RNA will indicate the presence of the CTCs in the peripheral blood sample.

Secondary Outcome Measures

Cancer specific survival in CTC positive CRC patients
The cancer specific survival in months will be measured from the time of diagnosis to the time of cancer related death. Two groups of patients will be compared: A: Patients with the presence of CEA mRNA positive CTCs in peripheral blood before colorectal cancer surgery as described in primary outcome measure. B: Patients with the absence of CEA mRNA positive CTCs in peripheral blood before colorectal cancer surgery as described in primary outcome measure.

Full Information

First Posted
October 26, 2017
Last Updated
October 11, 2019
Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT03337347
Brief Title
Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients
Official Title
Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2004 (Actual)
Primary Completion Date
February 28, 2007 (Actual)
Study Completion Date
October 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine whether the presence of circulating/disseminated tumor cells (CTCs/DTCs) in the blood and bone marrow of colorectal cancer (CRC) patients with localized disease is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Circulating Tumor Cell
Keywords
Prognostic significance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CTC/DTC count
Intervention Description
The presence of CTCs/DTCs in the peripheral blood and/or bone marrow may identify colorectal cancer patients with high risk of disease recurrence who may benefit from adjuvant therapy.
Primary Outcome Measure Information:
Title
CEA mRNA positive circulating tumor cells in colorectal cancer patients
Description
The absolute gene expression of carcinoembryonic antigen (CEA mRNA) in circulating tumor cells (CTCs) purified from peripheral blood of patients before colorectal surgery will be measured using real-time RT-PCR method. The CEA gene expression will be normalized per microgram of total mRNA. The cut-off values identifying presence or absence of CEA mRNA positive CTCs in patients was established using the maxstat() function from the maxstat R package as a mode value of estimates obtained for 10 000 random samples. CEA mRNA levels above 190 CEA mRNA copies per microgram of RNA will indicate the presence of the CTCs in the peripheral blood sample.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Cancer specific survival in CTC positive CRC patients
Description
The cancer specific survival in months will be measured from the time of diagnosis to the time of cancer related death. Two groups of patients will be compared: A: Patients with the presence of CEA mRNA positive CTCs in peripheral blood before colorectal cancer surgery as described in primary outcome measure. B: Patients with the absence of CEA mRNA positive CTCs in peripheral blood before colorectal cancer surgery as described in primary outcome measure.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - colorectal adenocarcinoma Exclusion Criteria: prior neoadjuvant chemoradiotherapy prior colorectal cancer cancer duplicity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miloslav Duda, MD
Organizational Affiliation
University Hospital Olomouc
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified primary data will be available

Learn more about this trial

Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients

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