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NCT Number: NCT03640572

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

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.

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Key information

Conditions

Colorectal Cancer Bone Marrow Tumor Cell Infiltration Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1st Department of General Surgery

Krakow, Malopolska, 31-501, Poland

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow analysis to identify disseminated tumour cells

Diagnostic Test

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.

Primary outcomes

  1. Overall survival (OS)

    Time frame: 5 years

    OS in patients with and without DTC in bone marrow

Secondary outcomes

  1. Local recurrence rate

    Time frame: 5 years

    Local recurrence in patients with and without DTC in bone marrow

  2. Systemic recurrence

    Time frame: 5 years

    Systemic recurrence in patients with and without DTC in bone marrow

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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