Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

Study Overview
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Brief Summary
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The purpose of this research study is to understand if platelets in the blood become more active during cancer and specially advanced stages of cancer, in the future the investigators want to see if reducing platelet activity can improve survival in advanced cancer.

Detailed Description
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Hypotheses for proposed study Platelet reactivity as measured by percentage aggregation in response to agonists such as ADP is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls. Platelet activation as measured by release of cytokines and vasoactive substances such as VEGF, TGF-beta, and PDGF is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls. Study Design: Single center matched case control design; matching variables are age, sex and ethnicity Inclusion Criteria Cases: 25 adult patients (>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy. Controls: 25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic. Exclusion Criteria: Thrombocytopenia, defined as a platelet count of <100,000 at the time of recruitment of in the last available laboratory data History of known bleeding disorder or known platelet dysfunction Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing CKD stage IV or greater

Official Title
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Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

Conditions
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Neoplasm

Intervention / Treatment
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* Drug: Everolimus
* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases: 25 adult patients (>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy. Controls: 25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic. Exclusion Criteria: Thrombocytopenia, defined as a platelet count of <100,000 at the time of recruitment of in the last available laboratory data History of known bleeding disorder or known platelet dysfunction Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing CKD stage IV or greater

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Cases<br>Patients with cancer whose platelets are examined | |
| Placebo Comparator: Control<br>Patients without cancer whose platelets are examined for comparison | Drug: Everolimus<br>* 10 mg of Everolimus daily (by mouth)<br>Drug: Letrozole<br>* 2.5mg taken daily (by mouth)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Release of vasoactive substances, e.g. TGF Beta, |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Activation, metastasis