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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03717519
Other study ID # CHIR CR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date September 1, 2018

Study information

Verified date July 2023
Source Azienda Ospedaliera Universitaria Integrata Verona
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Colorectal cancer (CRC) is the third most common malignancy worldwide and is often metastatic at diagnosis. Despite progresses in surgical techniques and the introduction of novel chemotherapy regimens, many patients still suffer from a poor prognosis. It is therefore of utmost importance to identify prognostic markers that may improve selection of patients. In recent years several studies demonstrated that preoperative blood tests as platelet count or neuthophil-to-lymphocyte ratio could be prognostic factors in CRC as well as other malignancies. The aim of this study was to evaluate the role of preoperative platelet count (PC) in patients with synchronous colorectal liver metastases.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date September 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Colorectal cancer with synchronous liver metastases - Possibility to retrieve pre-operative platelet count - Age of 18 years or older - Availabilty of clinical-pathological data - Minimum follow up of 12 months Exclusion Criteria: - None

Study Design


Intervention

Diagnostic Test:
Measurement of platelet count at diagnosis
Blood samples were drawn by expert phlebotomists in vacuum blood tubes containing K2-EDTA (Terumo Europe NV, Leuven, Belgium). The complete blood cell count (CBC) was performed using Advia 2120 (Siemens Healthcare Diagnostics, Tarrytown NY, USA). The local reference range for platelets was 150-400 x 109/L. The same analyser was used throughout the study period, and the quality and reproducibility of test results was validated by data of both internal quality control and external quality assessment

Locations

Country Name City State
Italy Chirurgia Generale ed Epatobiliare, Policlinico GB Rossi Verona

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Baranyai Z, Krzystanek M, Josa V, Dede K, Agoston E, Szasz AM, Sinko D, Szarvas V, Salamon F, Eklund AC, Szallasi Z, Jakab F. The comparison of thrombocytosis and platelet-lymphocyte ratio as potential prognostic markers in colorectal cancer. Thromb Haemost. 2014 Mar 3;111(3):483-90. doi: 10.1160/TH13-08-0632. Epub 2013 Nov 28. — View Citation

Pedrazzani C, Mantovani G, Fernandes E, Bagante F, Luca Salvagno G, Surci N, Campagnaro T, Ruzzenente A, Danese E, Lippi G, Guglielmi A. Assessment of neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio and platelet count as predictors of long-term outcome after R0 resection for colorectal cancer. Sci Rep. 2017 May 4;7(1):1494. doi: 10.1038/s41598-017-01652-0. — View Citation

Wan S, Lai Y, Myers RE, Li B, Hyslop T, London J, Chatterjee D, Palazzo JP, Burkart AL, Zhang K, Xing J, Yang H. Preoperative platelet count associates with survival and distant metastasis in surgically resected colorectal cancer patients. J Gastrointest Cancer. 2013 Sep;44(3):293-304. doi: 10.1007/s12029-013-9491-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival correlation between high PC and overall survival 5 years
Secondary Clinic-pathological variables correlation between high PC and clinic-pathological variables 30 days
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