Colorectal CancerPLTCRCNCT03717519
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases
An observational study of Colorectal Cancer and Colorectal Carcinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Carcinoma, Stage IV Colon Cancer
- What is being tested?
- Measurement of platelet count at diagnosis
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent surgery for colorectal cancer with synchronous liver metastases in the study period, and who fulfilled the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site
Chirurgia Generale ed Epatobiliare, Policlinico GB Rossi
Verona, 37134
About this study
Official title: 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.
- Being tested
- Measurement of platelet count at diagnosis
- Keywords
- platelets, thrombocytosis, prognosis
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Thrombocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of platelet count at diagnosisDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| s-CRLM | Patients with synchronous colorectal liver metastases who underwent surgical resection Receives: Diagnostic Test: Measurement of platelet count at diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
correlation between high PC and overall survival
Measured: 5 years
Secondary outcomes (1)
Clinic-pathological variables
correlation between high PC and clinic-pathological variables
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrado Pedrazzani, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Corrado Pedrazzani, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717519
- Sponsor's protocol ID
- CHIR CR
- Acronym
- PLTCRC
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2018
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28473700Wan 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.
PubMed 23549858Baranyai 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.
PubMed 24285160
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases: a Retrospective Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT03717519
- Acronym / sponsor ID
- PLTCRC / CHIR CR
- Keywords
- platelets, thrombocytosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| s-CRLM | – | Diagnostic Test: Measurement of platelet count at diagnosisPatients with synchronous colorectal liver metastases who underwent surgical resection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery for colorectal cancer with synchronous liver metastases in the study period, and who fulfilled the inclusion criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of platelet count at diagnosisBlood 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 | Diagnostic test | s-CRLM |
Primary outcome
Overall survival
Time frame: 5 years
correlation between high PC and overall survival
1 secondary outcome
Clinic-pathological variables
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 28473700Pedrazzani 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.
- Background: PubMed 23549858Wan 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.
- Background: PubMed 24285160Baranyai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrado Pedrazzani, MD principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Carcinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03717519, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.