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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

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ClinicalTrials.gov Identifier: NCT02450175
Recruitment Status : Unknown
Verified May 2015 by Kenneth Miller, M.D., Sinai Hospital of Baltimore.
Recruitment status was:  Recruiting
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Kenneth Miller, M.D., Sinai Hospital of Baltimore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasm Drug: Everolimus Drug: Letrozole Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Cases
Patients with cancer whose platelets are examined
Placebo Comparator: Control
Patients without cancer whose platelets are examined for comparison
Drug: Everolimus
10 mg of Everolimus daily (by mouth)

Drug: Letrozole
2.5mg taken daily (by mouth)




Primary Outcome Measures :
  1. Platelet reactivity [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Release of vasoactive substances, e.g. TGF Beta, [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450175


Locations
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United States, Maryland
SInai Hospital of Baltimore, Inc. Recruiting
Baltimore, Maryland, United States, 21215
Contact: Judy Bosley, BSN, RN    410-601-6120    jbosley@lifebridgehealth.org   
Contact: Paulette Ridgely, RN    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Kenneth Miller, MD         
Sponsors and Collaborators
Sinai Hospital of Baltimore
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Responsible Party: Kenneth Miller, M.D., Medical Oncologist, Sinai Hospital of Baltimore
ClinicalTrials.gov Identifier: NCT02450175    
Other Study ID Numbers: EOTPCMP
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Kenneth Miller, M.D., Sinai Hospital of Baltimore:
Platelet Activation
metastasis
Additional relevant MeSH terms:
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Everolimus
Letrozole
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists