Evaluation of Platelet Aggregability in Patients with Non-small Cell Lung Carcinomas

March 6, 2025 updated by: Jose Carlos Nicolau, University of Sao Paulo

Cancer patients are at greater risk of experiencing events thrombotic, arterial or venous, during the course of the disease. Specifically in lung cancer, patients are seven times more prone to developing venous thrombosis, when compared to general population. Platelets influence cancer progression and Tumor microenvironment facilitates platelet activation. Therefore, the main objective of this project is to evaluate platelet aggregation analyzed by aggregometry optics with the use of AggRAM® equipment in patients diagnosed recent non-small cell lung carcinomas, prior to any oncological treatment. Among the secondary objectives, it stands out analyze the primary objective using the PPAnalysis® method (method in developed by our group in partnership with the University of Readings (UK), Plateletworks® and Chrono-log. This is a case-control study, with groups differentiated by the presence or absence of malignant lung neoplasia and matched by age, sex and presence or absence of smoking in the previous 6 months to inclusion. Patients diagnosed with non-cell lung carcinoma Small children without prior treatment will be candidates for participation in the study.

It is expected that at the end important aspects related to aggregation platelet disease are better characterized in this neoplasm, the most important cause of death from cancer in the world, and therapeutic strategies to improvement in morbidity and mortality in the disease can be developed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer patients are at increased risk of thrombotic complications, especially venous thromboembolism (VTE). The oncology population is seven times more likely to develop thrombosis when compared to the general population, with an incidence of up to 20% of patients during follow-up. It is suggested that the reasons for this greater thrombotic risk are immobility, invasive procedures and changes in coagulation, in addition to possible disorders of platelet aggregation and endothelial function.

The literature suggests that the basic thromboembolic mechanism would be related to the production, by tumor cells, of pro-coagulant factors such as tissue factor and neoplastic pro-coagulant. PAI-1, the main inhibitor of the plasminogen activator pathway, is also produced by tumor cells. Still, tumor production of factors inhibiting the fibrinolytic system plays a role in hypercoagulability and may contribute to tumor angiogenesis. Regarding arterial thrombotic events, although there is no unanimity regarding the causal relationship between the pathologies, epidemiological data strongly suggest that this complication is more common in patients with cancer, compared to the population without the disease.

It is worth mentioning that lung cancer is the most common cause of cancer deaths in the world. It is possible that the high mortality from lung cancer is related, at least partially, to the higher incidence of thrombotic complications presented by these patients, compared to those with other types of cancer. Although VTE is one of the main causes of morbidity and mortality in cancer patients, the use of anticoagulants as primary prophylaxis is not routinely recommended.

The pathophysiological mechanisms involved in the increased risk of thromboembolic events in cancer patients, especially with lung cancer, which, as mentioned, present, in addition to the aggressiveness of the disease itself, a higher incidence of thrombotic events, are still little known. The main objective of this project is to contribute to a better understanding of the mechanisms involved in thrombotic events in the population with lung cancer, with clear therapeutic impacts.

This is a case-control study with groups differentiated by the presence or absence of NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion. Patients diagnosed with NSCLC without prior treatment for the disease will be candidates for participation in the study.

The primary objective is to compare platelet aggregability by optical aggregometry assessed by the AggRAM® method in patients diagnosed with NSCLC, prior to any oncological treatment, in relation to a control group matched by sex, age and presence or absence of smoking in the previous 6 months. to inclusion Secondary objetives includes laboratorial test of inflammation, coagulation and subgroup analysis.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 3

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

  • Brazil
      • São Paulo, Brazil
        • Heart Institute (InCor) / University of São Paulo

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients > 18 years old;
  • Confirmed diagnosis of non-small cell lung carcinoma in the case group; absence of history of any neoplasia for control group
  • Agreement to sign the Free and Informed Consent Form

Exclusion Criteria:

  • Anticoagulation in the last 30 days;
  • Use of any antiplatelet agent in the last 30 days;
  • Use of any non-steroidal anti-inflammatory drugs in the last 30 days;
  • Known platelet dysfunction or platelets <100,000/mm3 or >450,000/mm3;
  • Creatinine clearance by MDRD <30 ml/min/1.73 m2
  • Eastern Cooperative Oncology Group Performance Status Scale (ECOG) >2
  • Known coagulation disorder;
  • Hematocrit less than 34% or greater than 55%

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control (group 1)
patients without NSCLC and matched by age, sex and presence or absence of smoking in the 6 months before inclusion
Drug: Clopidogrel
Clopidogrel 75 mg uma vez ao dia durante 14 dias
Active Comparator: case (group 2)
patients with NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion
Drug: Clopidogrel
Clopidogrel 75 mg uma vez ao dia durante 14 dias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)
Time Frame: 14 days
Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of ultrasensitive C-reactive protein (hs-CRP);
Time Frame: Baseline
Avaliation of Serum levels of ultrasensitive C-reactive protein (hs-CRP)
Baseline
Serum levels of Lipoprotein(a) (LPa)
Time Frame: Baseline
Evaluation of Serum levels of Lipoprotein(a) (LPa)
Baseline
Serum levels of P-Selectin
Time Frame: Baseline
Evaluation of Serum levels of P-Selectin
Baseline
Serum levels of Interleukin 1
Time Frame: Baseline
Evaluation of interleukin 1
Baseline
Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day
Time Frame: 14 days
Evaluation of Platelet aggregability by AggRAM™ ADP after 14 days of use of Clopidogrel 75 mg/day
14 days
Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day
Time Frame: 14 days
Evaluation of Platelet aggregability by Plateletworks-ADP at baseline and after 14 days of use of Clopidogrel 75 mg/day
14 days
Serum levels of tissue factor
Time Frame: Baseline
Evaluation of Serum levels of tissue factor
Baseline
Serum levels of type I plasminogen activator inhibitor (PAI 1)
Time Frame: Baseline
Evaluation of Serum levels of type I plasminogen activator inhibitor (PAI 1)
Baseline
Serum levels of immature platelets
Time Frame: Baseline
Evaluation of Serum levels of immature platelets
Baseline
Serum levels of interleukin 6
Time Frame: Baseline
Evaluation of Serum levels of interleukin 6
Baseline
Serum levels of D-dimero
Time Frame: Baseline
Evaluation of Serum levels of D-dimero
Baseline
Serum levels of Glycated hemoglobin
Time Frame: Baseline
Evaluation of Serum levels of Glycated hemoglobin
Baseline
Serum levels of coagulogram
Time Frame: Baseline
Evaluation of Serum levels of coagulogram
Baseline
Serum levels of Fibrinogen
Time Frame: Baseline
Evaluation of Serum levels of Fibrinogen
Baseline
Serum levels of cholesterol ester transfer proteins
Time Frame: Baseline
Evaluation of Serum levels of cholesterol ester transfer proteins
Baseline
Serum levels of blood count with platelets
Time Frame: Baseline
Evaluation of Serum levels of blood count with platelets
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup Analysis- Sex
Time Frame: Baseline and 14 days
Sex (male/female)
Baseline and 14 days
Subgroup Analysis- Age
Time Frame: Baseline and 14 days
Age (≥65 years or < 65 years)
Baseline and 14 days
Subgroup Analysis- Diabetes mellitus
Time Frame: Baseline and 14 days
Diabetes mellitus (presence or not)
Baseline and 14 days
Subgroup Analysis-Glomerular filtration rate
Time Frame: Baseline and 14 days
Glomerular filtration rate (CKD EPI) (< 60ml/min/m2 or ≥ 60 ml/min/m2)
Baseline and 14 days
Subgroup Analysis- BDI
Time Frame: Baseline and 14 days
Body Mass Index (<30 or ≥ 30 kg/m2)
Baseline and 14 days
Subgroup Analysis- Smoking
Time Frame: Baseline and 14 days
Current smoking (yes or no)
Baseline and 14 days

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

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.

General Publications

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 20, 2025

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 20, 2027

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5788/23/190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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