Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

Neoplasm Clinical Trial

Official title:

Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450175
• Other study ID #: EOTPCMP
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2015
• Last updated: May 20, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2015
• Source: Sinai Hospital of Baltimore
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neoplasm

Intervention

Drug:
• Everolimus
10 mg of Everolimus daily (by mouth)
• Letrozole
2.5mg taken daily (by mouth)

Locations

Country	Name	City	State
United States	SInai Hospital of Baltimore, Inc.	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sinai Hospital of Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity		1 day	No
Secondary	Release of vasoactive substances, e.g. TGF Beta,		1 day	No