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

NCT03640572 | Completed DMC

• 1 other identifier: DCT LSCC
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Bone Marrow Tumor Cell Infiltration

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS in patients with and without DTC in bone marrow

  5 years

Secondary Outcomes (2)

• Local recurrence rate

  5 years

• Systemic recurrence

  5 years

Study Arms (2)

Bone Marrow DTC

Patients with left-sided colorectal cancer and disseminated tumour cells in the bone marrow

Diagnostic Test: Bone marrow analysis to identify disseminated tumour cells

No bone marrow DTC

Patients with left-sided colorectal cancer and no disseminated tumour cells in the bone marrow

Diagnostic Test: Bone marrow analysis to identify disseminated tumour cells

Interventions

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.

Bone Marrow DTC; No bone marrow DTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with left-sided colorectal cancer operated on in one tertiary centre.

You may qualify if:

• age \> 18 years
• histologically proven left-sided colorectal cancer
• signed informed consent

You may not qualify if:

• synchronous right sided colon cancer
• history of other neoplasm
• inability to understand and sign informed consent

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

1st Department of General Surgery

Krakow, Malopolska, 31-501, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone Marrow biopsy

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Antoni Szczapanik, Assoc. Prof.

  Jagiellonian diversity

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: June 1, 2007
• Primary Completion: December 31, 2012
• Study Completion: December 30, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

PL (1)