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

NCT03337347 | Completed

• 1 other identifier: CTC_CRC_2017
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Circulating Tumor Cell

Keywords

Prognostic significance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cancer specific survival in CTC positive CRC patients

  10 years

Interventions

CTC/DTC count DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- colorectal adenocarcinoma

You may not qualify if:

• prior neoadjuvant chemoradiotherapy
• prior colorectal cancer
• cancer duplicity

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Miloslav Duda, MD

  University Hospital Olomouc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 9, 2017
• Study Start: January 1, 2004
• Primary Completion: February 28, 2007
• Study Completion: October 23, 2015
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)