Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases (PLTCRC)

July 19, 2023 updated by: Corrado Pedrazzani, Azienda Ospedaliera Universitaria Integrata Verona

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

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Verona, Italy, 37134
        • Chirurgia Generale ed Epatobiliare, Policlinico GB Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who underwent surgery for colorectal cancer with synchronous liver metastases in the study period, and who fulfilled the inclusion criteria.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
s-CRLM
Patients with synchronous colorectal liver metastases who underwent surgical resection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
correlation between high PC and overall survival
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinic-pathological variables
Time Frame: 30 days
correlation between high PC and clinic-pathological variables
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Corrado Pedrazzani, MD, Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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