Disseminated Tumour Cells (DTC) in Left Sided Colorectal Cancer (LSCC).

Colorectal Cancer Clinical Trial

Official title:

Prognostic Value of Disseminated Tumour Cells in Bone Marrow in Patients With Left-sided Colorectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640572
• Other study ID #: DCT LSCC
• Status: Completed
• Start date: June 1, 2007
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2019
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Two metaanalyses of studies on the prognostic significance of circulating cancer cells in colorectal cancer indicated, that the presence of circulating tumour cells (CTC) in the peripheral blood is the negative prognostic factor. However there is no sufficient evidence that disseminated tumour cells (DTC) in the bone marrow of the colorectal cancer patients influence the prognosis. There is the evidence that right-sided and left- sided cancers may have different biology and different prognosis. Therefore in this study the investigators concentrated on the left colon and rectum locations with the locally advanced cancer being the main area of interest.

The aim of this study was to analyse the relation of DTC with the tumor characteristics, cancer progression and survival in left sided colorectal cancer.

Description:

A group of 91 colorectal patients treated in a single institution was involved into the study. Only the patients with tumors located in the rectum or left side colon were included. The term left colon was defined as the left 1/3 of transverse colon and all the colon parts distally from this point. None of the colon cancer patients received preoperative chemotherapy, while 5 of the rectal cancer patients received preoperative radiotherapy and two preoperative radiochemotherapy. There were 42 women and 49 men, the mean age 64,7 (SD - standard deviation 10,2). The bone marrow biopsy was performed on the day of surgery after the induction of general anesthesia from posterior superior iliac spine. The 5ml sample of the bone marrow was collected to plastic tubes containing EthyleneDiamineTetraacetic (EDTA). Patients received postoperative chemotherapy if indicated, regardless of their DTC status. All the patients were followed up at least for 5 years or until death.

The incidence of DTC was not related to the depth of infiltration (T feature) being similar in T1-2 and T4 patients. There was no statistically significant difference between the incidence of DTC in N- and N+ patients. The 5 years survival rate for the DTC patients was 59,5% while for the DTC negative patients was 53%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 30, 2018
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• histologically proven left-sided colorectal cancer

• signed informed consent

Exclusion Criteria:

• synchronous right sided colon cancer

• history of other neoplasm

• inability to understand and sign informed consent

Related Conditions & MeSH terms

• Bone Marrow Neoplasms
• Bone Marrow Tumor Cell Infiltration
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Bone marrow analysis to identify disseminated tumour cells
Pelleted cells from bone marrow samples were incubated with an excessive amount of lysing solution for 10 min, repeated 3-4 times to remove erythrocytes. The slides were dried, fixed with a mixture of ethanol and acetone (1 : 1 v v-1), and then stained for 30 min with A45-B/B3 monoclonal antibodies (5 µg ml-1) (Micromet GmbH, Germany), which recognise common epitopes of cytokeratins (CK) including CK 8, 18 and 19.

Locations

Country	Name	City	State
Poland	1st Department of General Surgery	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS in patients with and without DTC in bone marrow	5 years
Secondary	Local recurrence rate	Local recurrence in patients with and without DTC in bone marrow	5 years
Secondary	Systemic recurrence	Systemic recurrence in patients with and without DTC in bone marrow	5 years