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
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm||Drug: Everolimus Drug: Letrozole||Not Applicable|
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.
Single center matched case control design; matching variables are age, sex and ethnicity
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.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
No Intervention: Cases
Patients with cancer whose platelets are examined
Placebo Comparator: Control
Patients without cancer whose platelets are examined for comparison
10 mg of Everolimus daily (by mouth)
2.5mg taken daily (by mouth)
- Platelet reactivity [ Time Frame: 1 day ]
- Release of vasoactive substances, e.g. TGF Beta, [ Time Frame: 1 day ]
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
|United States, Maryland|
|SInai Hospital of Baltimore, Inc.||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Judy Bosley, BSN, RN 410-601-6120 email@example.com|
|Contact: Paulette Ridgely, RN 410-601-6120 firstname.lastname@example.org|
|Principal Investigator: Kenneth Miller, MD|