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

NCT06872541 | Active Not Recruiting Phase 2

• 1 other identifier: 5788/23/190
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Assessment of Platelet Aggregability in Patients Patients with Non-small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Platelet Aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratories)

  Compare platelet aggregation analyzed by optical aggregometry-ADP (AggRAM™- Helena Laboratórios) between both groups

  14 days

Secondary Outcomes (16)

• 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

  14 days

• Serum levels of tissue factor

  Baseline

• Serum levels of type I plasminogen activator inhibitor (PAI 1)

  Baseline

• Serum levels of immature platelets

  Baseline

Other Outcomes (6)

• Subgroup Analysis- Age

  Baseline and 14 days

• Subgroup Analysis- Sex

  Baseline and 14 days

• Subgroup Analysis- Diabetes mellitus

  Baseline and 14 days

Study Arms (2)

control (group 1)

ACTIVE COMPARATOR

patients without NSCLC and matched by age, sex and presence or absence of smoking in the 6 months before inclusion

Drug: Clopidogrel

case (group 2)

ACTIVE COMPARATOR

patients with NSCLC and matched by age, sex and presence or absence of smoking in the 6 months prior to inclusion

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Clopidogrel 75 mg uma vez ao dia durante 14 dias

case (group 2); control (group 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (13)

• Fuentes HE, Oramas DM, Paz LH, Casanegra AI, Mansfield AS, Tafur AJ. Meta-analysis on anticoagulation and prevention of thrombosis and mortality among patients with lung cancer. Thromb Res. 2017 Jun;154:28-34. doi: 10.1016/j.thromres.2017.03.024. Epub 2017 Apr 1.

  PMID: 28402864 BACKGROUND

• Mutlu H, Artis TA, Erden A, Akca Z. Alteration in mean platelet volume and platicrit values in patients with cancer that developed thrombosis. Clin Appl Thromb Hemost. 2013 Jun;19(3):331-3. doi: 10.1177/1076029611433644. Epub 2012 Feb 16.

  PMID: 22345488 BACKGROUND

• Zacharski LR, Henderson WG, Rickles FR, Forman WB, Cornell CJ Jr, Forcier RJ, Edwards RL, Headley E, Kim SH, O'Donnell JF, et al. Effect of warfarin anticoagulation on survival in carcinoma of the lung, colon, head and neck, and prostate. Final report of VA Cooperative Study #75. Cancer. 1984 May 15;53(10):2046-52. doi: 10.1002/1097-0142(19840515)53:103.0.co;2-f.

  PMID: 6322957 BACKGROUND

• Ek L, Gezelius E, Bergman B, Bendahl PO, Anderson H, Sundberg J, Wallberg M, Falkmer U, Verma S, Belting M; Swedish Lung Cancer Study Group (SLUSG). Randomized phase III trial of low-molecular-weight heparin enoxaparin in addition to standard treatment in small-cell lung cancer: the RASTEN trial. Ann Oncol. 2018 Feb 1;29(2):398-404. doi: 10.1093/annonc/mdx716.

  PMID: 29106448 BACKGROUND

• Macbeth F, Noble S, Evans J, Ahmed S, Cohen D, Hood K, Knoyle D, Linnane S, Longo M, Moore B, Woll PJ, Appel W, Dickson J, Ferry D, Brammer C, Griffiths G. Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial. J Clin Oncol. 2016 Feb 10;34(5):488-94. doi: 10.1200/JCO.2015.64.0268. Epub 2015 Dec 23.

  PMID: 26700124 BACKGROUND

• Altinbas M, Coskun HS, Er O, Ozkan M, Eser B, Unal A, Cetin M, Soyuer S. A randomized clinical trial of combination chemotherapy with and without low-molecular-weight heparin in small cell lung cancer. J Thromb Haemost. 2004 Aug;2(8):1266-71. doi: 10.1111/j.1538-7836.2004.00871.x.

  PMID: 15304029 BACKGROUND

• Meikle CK, Meisler AJ, Bird CM, Jeffries JA, Azeem N, Garg P, Crawford EL, Kelly CA, Gao TZ, Wuescher LM, Willey JC, Worth RG. Platelet-T cell aggregates in lung cancer patients: Implications for thrombosis. PLoS One. 2020 Aug 10;15(8):e0236966. doi: 10.1371/journal.pone.0236966. eCollection 2020.

  PMID: 32776968 BACKGROUND

• Navi BB, Reiner AS, Kamel H, Iadecola C, Okin PM, Elkind MSV, Panageas KS, DeAngelis LM. Risk of Arterial Thromboembolism in Patients With Cancer. J Am Coll Cardiol. 2017 Aug 22;70(8):926-938. doi: 10.1016/j.jacc.2017.06.047.

  PMID: 28818202 BACKGROUND

• Mangalpally KK, Siqueiros-Garcia A, Vaduganathan M, Dong JF, Kleiman NS, Guthikonda S. Platelet activation patterns in platelet size sub-populations: differential responses to aspirin in vitro. J Thromb Thrombolysis. 2010 Oct;30(3):251-62. doi: 10.1007/s11239-010-0489-x.

  PMID: 20502945 BACKGROUND

• Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.

  PMID: 10737280 BACKGROUND

• Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22. doi: 10.1001/jama.293.6.715.

  PMID: 15701913 BACKGROUND

• Metharom P, Falasca M, Berndt MC. The History of Armand Trousseau and Cancer-Associated Thrombosis. Cancers (Basel). 2019 Jan 31;11(2):158. doi: 10.3390/cancers11020158.

  PMID: 30708967 BACKGROUND

• Marks MA, Engels EA. Venous thromboembolism and cancer risk among elderly adults in the United States. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):774-83. doi: 10.1158/1055-9965.EPI-13-1138. Epub 2014 Mar 8.

  PMID: 24608188 BACKGROUND

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

BR (1)