- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717519
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases (PLTCRC)
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases: a Retrospective Single-center Cohort Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Verona, Italy, 37134
- Chirurgia Generale ed Epatobiliare, Policlinico GB Rossi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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s-CRLM
Patients with synchronous colorectal liver metastases who underwent surgical resection
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall survival
Time Frame: 5 years
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correlation between high PC and overall survival
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinic-pathological variables
Time Frame: 30 days
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correlation between high PC and clinic-pathological variables
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30 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Corrado Pedrazzani, MD, Azienda Ospedaliera Universitaria Integrata Verona
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Myeloproliferative Disorders
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Blood Platelet Disorders
- Colorectal Neoplasms
- Thrombocytosis
Other Study ID Numbers
- CHIR CR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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