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

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ClinicalTrials.gov Identifier: NCT03717519
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Corrado Pedrazzani, Azienda Ospedaliera Universitaria Integrata Verona

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.


Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Carcinoma Stage IV Colon Cancer Diagnostic Test: Measurement of platelet count at diagnosis

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Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases: a Retrospective Single-center Cohort Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    correlation between high PC and overall survival


Secondary Outcome Measures :
  1. Clinic-pathological variables [ Time Frame: 30 days ]
    correlation between high PC and clinic-pathological variables



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717519


Locations
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Italy
Chirurgia Generale ed Epatobiliare, Policlinico GB Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
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Principal Investigator: Corrado Pedrazzani, MD Azienda Ospedaliera Universitaria Integrata Verona

Publications:
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Responsible Party: Corrado Pedrazzani, Principal Investigator, Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03717519    
Other Study ID Numbers: CHIR CR
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corrado Pedrazzani, Azienda Ospedaliera Universitaria Integrata Verona:
platelets
thrombocytosis
prognosis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Thrombocytosis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases