NCT03717519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

October 22, 2018

Last Update Submit

July 19, 2023

Conditions

Keywords

plateletsthrombocytosisprognosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    correlation between high PC and overall survival

    5 years

Secondary Outcomes (1)

  • Clinic-pathological variables

    30 days

Study Arms (1)

s-CRLM

Patients with synchronous colorectal liver metastases who underwent surgical resection

Diagnostic Test: Measurement of platelet count at diagnosis

Interventions

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

s-CRLM

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chirurgia Generale ed Epatobiliare, Policlinico GB Rossi

Verona, 37134, Italy

Location

Related Publications (3)

  • 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.

    PMID: 28473700BACKGROUND
  • 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.

    PMID: 23549858BACKGROUND
  • 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.

    PMID: 24285160BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsThrombocytosis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersBone Marrow Diseases

Study Officials

  • Corrado Pedrazzani, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations