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

Sinai Hospital of Baltimore50 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Neoplasm

Interventions

EverolimusDRUG

10 mg of Everolimus daily (by mouth)

LetrozoleDRUG

2.5mg taken daily (by mouth)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SInai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Platelet reactivity

Time frame: 1 day

Secondary Outcomes

Release of vasoactive substances, e.g. TGF Beta,

Time frame: 1 day

Data from ClinicalTrials.gov

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