Clinical trial NCT03640572: Disseminated Tumour Cells (DTC) in Left Sided Colorectal Cancer (LSCC).
Official title: Prognostic Value of Disseminated Tumour Cells in Bone Marrow in Patients With Left-sided Colorectal Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Bone Marrow Tumor Cell Infiltration
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with left-sided colorectal cancer operated on in one tertiary centre.

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: Local recurrence rate
timeFrame: 5 years
measure: Systemic recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: 1st Department of General Surgery
state: Malopolska
Study officials:
affiliation: Jagiellonian diversity
name: Antoni Szczapanik, Assoc. Prof.
role: STUDY_CHAIR
References: