Neoplasm
Conditions
Keywords
Platelet Activation, metastasis
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.
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
Interventions
DRUGEverolimus
10 mg of Everolimus daily (by mouth)
DRUGLetrozole
2.5mg taken daily (by mouth)
Sponsors
Sinai Hospital of Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet reactivity | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Release of vasoactive substances, e.g. TGF Beta, | 1 day |
Countries
United States
Outcome results
None listed