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

Completed

• Conditions: Bone Marrow Tumor Cell Infiltration; Colorectal Cancer
• Interventions: Diagnostic Test: Bone marrow analysis to identify disseminated tumour cells

• Registration Number: NCT03640572
• Lead Sponsor: Jagiellonian University

Brief 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.

Detailed 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%.

Study Timeline

• Study Start: 2007-06-01
• Primary Completion: 2012-12-31
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Completion: 2018-12-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone Marrow DTC	Bone marrow analysis to identify disseminated tumour cells	Patients with left-sided colorectal cancer and disseminated tumour cells in the bone marrow
No bone marrow DTC	Bone marrow analysis to identify disseminated tumour cells	Patients with left-sided colorectal cancer and no disseminated tumour cells in the bone marrow

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years	OS in patients with and without DTC in bone marrow

Secondary Outcome Measures

Name	Time	Method
Local recurrence rate	5 years	Local recurrence in patients with and without DTC in bone marrow
Systemic recurrence	5 years	Systemic recurrence in patients with and without DTC in bone marrow

Trial Locations

Locations (1)

1st Department of General Surgery; 🇵🇱 Kraków, Malopolska, Poland