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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337347
• Other study ID #: CTC_CRC_2017
• Status: Completed
• Phase: N/A
• Start date: January 1, 2004
• Est. completion date: October 23, 2015

Study information

• Verified date: October 2019
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: October 23, 2015
• Est. primary completion date: February 28, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• colorectal adenocarcinoma

Exclusion Criteria:

• prior neoadjuvant chemoradiotherapy

• prior colorectal cancer

• cancer duplicity

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplastic Cells, Circulating

Intervention

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.

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	10 years