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

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ClinicalTrials.gov Identifier: NCT03337347
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
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

Resource links provided by the National Library of Medicine



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.


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.




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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


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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
Czechia
University Hospital Olomouc
Olomouc, Czechia, 77900
Sponsors and Collaborators
The Institute of Molecular and Translational Medicine, Czech Republic
Investigators
Principal Investigator: Miloslav Duda, MD University Hospital Olomouc

Responsible Party: Marian Hajduch, M.D., Ph.D., Director, The Institute of Molecular and Translational Medicine, Czech Republic
ClinicalTrials.gov Identifier: NCT03337347     History of Changes
Other Study ID Numbers: CTC_CRC_2017
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified primary data will be available

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic:
Prognostic significance

Additional relevant MeSH terms:
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