Recruiting

Observational Study

Sponsor:

Sinai Hospital of Baltimore

Code:

NCT02450175

Conditions

Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Everolimus

Letrozole

Study Details

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.

Conditions

Neoplasm

Study ID

NCT02450175

Start date

Jun, 2014

Status verified date

May, 2015

Completion date

Jun, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Cases

Patients with cancer whose platelets are examined

placebo comparator: Control

Patients without cancer whose platelets are examined for comparison

Interventions

Everolimus

10 mg of Everolimus daily (by mouth)

Letrozole

2.5mg taken daily (by mouth)

Primary outcome measure

  • Platelet reactivity [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

SInai Hospital of Baltimore, Inc.

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Principal Investigator:

Kenneth Miller, MD

More Information

Sponsor

Sinai Hospital of Baltimore

Last update posted

May 21, 2015

Last verified

May, 2015

Keywords

  • Platelet Activation
  • metastasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sinai Hospital of Baltimore on 2015-05-21.