Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
Study Details
Study Description
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 |
|---|---|---|
| N/A |
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
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Platelet reactivity [1 day]
Secondary Outcome Measures
- Release of vasoactive substances, e.g. TGF Beta, [1 day]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SInai Hospital of Baltimore, Inc. | Baltimore | Maryland | United States | 21215 |
Sponsors and Collaborators
- Sinai Hospital of Baltimore
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EOTPCMP