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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337347
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
The Institute of Molecular and Translational Medicine, Czech Republic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Circulating Tumor Cell Device: CTC/DTC count Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients
Actual Study Start Date : January 1, 2004
Actual Primary Completion Date : February 28, 2007
Actual Study Completion Date : October 23, 2015
Arms and Interventions
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Intervention Details:
  • Device: CTC/DTC count
    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.

Outcome Measures
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Primary Outcome Measures :
  1. CEA mRNA positive circulating tumor cells in colorectal cancer patients [ Time Frame: 1 day ]
    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 :
  1. Cancer specific survival in CTC positive CRC patients [ Time Frame: 10 years ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- colorectal adenocarcinoma

Exclusion Criteria:

  • prior neoadjuvant chemoradiotherapy
  • prior colorectal cancer
  • cancer duplicity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337347


Locations
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Czechia
University Hospital Olomouc
Olomouc, Czechia, 77900
Sponsors and Collaborators
The Institute of Molecular and Translational Medicine, Czech Republic
Investigators
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Principal Investigator: Miloslav Duda, MD University Hospital Olomouc
More Information
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Responsible Party: The Institute of Molecular and Translational Medicine, Czech Republic
ClinicalTrials.gov Identifier: NCT03337347    
Other Study ID Numbers: CTC_CRC_2017
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified primary data will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Institute of Molecular and Translational Medicine, Czech Republic:
Prognostic significance
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes