NeoplasmNCT02450175
Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
A study testing Everolimus and Letrozole in people with Neoplasm, run by Sinai Hospital of Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasm
- What is being tested?
- Everolimus and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SInai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215
Judy Bosley, BSN, RN, 410-601-6120, jbosley@lifebridgehealth.org
Paulette Ridgely, RN, 410-601-6120, pridgely@lifebridgehealth.org
About this study
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.
Read the 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
- Conditions
- Neoplasm
- Being tested
- Everolimus, Letrozole
- Keywords
- Platelet Activation, metastasis
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
10 mg of Everolimus daily (by mouth)
LetrozoleDrug
2.5mg taken daily (by mouth)
| Study group | Role | What they receive |
|---|---|---|
| Cases | No intervention | Patients with cancer whose platelets are examined |
| Control | Placebo comparator | Patients without cancer whose platelets are examined for comparison Receives: Drug: Everolimus; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Measured: 1 day
Secondary outcomes (1)
Release of vasoactive substances, e.g. TGF Beta,
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai Hospital of Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Miller, M.D., Sinai Hospital of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450175
- Sponsor's protocol ID
- EOTPCMP
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
- ClinicalTrials.gov ID
- NCT02450175
- Acronym / sponsor ID
- EOTPCMP
- Conditions
- Neoplasm
- Keywords
- Platelet Activation, metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sinai Hospital of BaltimoreUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | No intervention | –Patients with cancer whose platelets are examined |
| Control | Placebo comparator | Drug: Everolimus, Drug: LetrozolePatients without cancer whose platelets are examined for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus10 mg of Everolimus daily (by mouth) | Drug | Control |
| Letrozole2.5mg taken daily (by mouth) | Drug | Control |
Primary outcome
Platelet reactivity
Time frame: 1 day
1 secondary outcome
Release of vasoactive substances, e.g. TGF Beta,
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everolimus and Letrozole in people with Neoplasm, run by Sinai Hospital of Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.