Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
NCT ID: NCT02450175
Last Updated: 2015-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-06-30
2016-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cases
Patients with cancer whose platelets are examined
No interventions assigned to this group
Control
Patients without cancer whose platelets are examined for comparison
Everolimus
10 mg of Everolimus daily (by mouth)
Letrozole
2.5mg taken daily (by mouth)
Interventions
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Everolimus
10 mg of Everolimus daily (by mouth)
Letrozole
2.5mg taken daily (by mouth)
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
Yes
Sponsors
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Sinai Hospital of Baltimore
OTHER
Responsible Party
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Kenneth Miller, M.D.
Medical Oncologist
Locations
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SInai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States
Countries
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Facility Contacts
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Other Identifiers
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EOTPCMP
Identifier Type: -
Identifier Source: org_study_id
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