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

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03337347
• Collaborator: (none)
• Enrollment: 256
• Location: 1
• Actual Duration (Months): 141.7
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Circulating Tumor Cell	Device: CTC/DTC count	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2004
• Actual Primary Completion Date: Feb 28, 2007
• Actual Study Completion Date: Oct 23, 2015

Outcome Measures

Primary Outcome Measures

1. CEA mRNA positive circulating tumor cells in colorectal cancer patients [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• colorectal adenocarcinoma

Exclusion Criteria:

• prior neoadjuvant chemoradiotherapy

• prior colorectal cancer

• cancer duplicity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Institute of Molecular and Translational Medicine, Czech Republic
• ClinicalTrials.gov Identifier: NCT03337347
• Other Study ID Numbers: CTC_CRC_2017
• First Posted: Nov 9, 2017
• Last Update Posted: Oct 15, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Colorectal Neoplasms; Neoplastic Cells, Circulating

Study Results

No Results Posted as of Oct 15, 2019