Advanced CancerNCT01543841
Laboratory Testing for Tie-2 Expressing Monocytes (TEMs) in Blood
An observational study of Advanced Cancer and Healthy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in healthy individuals and in people with cancer. These cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Healthy
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Jan 2014
- Phase
- Observational
- 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
Study population: Patients with advanced cancer attending the Phase I clinic and healthy staff at the Princess Margaret Hospital
Who may be able to join
- Healthy volunteers
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with advancer cancer
- Participants must have histologically confirmed metastatic or unresectable solid tumors.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Healthy volunteers
- History of cancer within the past 5 years
- Major medical condition undergoing active therapy
- Patients with advancer cancer
- Active hematologic malignancy (leukemia, lymphoma, myeloproliferative disorder).
- Active treatment on a Phase I clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Laboratory Evaluation of Tie-2 Expressing Monocytes (TEMs) in Healthy Volunteers and Patients With Advanced Cancer
Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in healthy individuals and in people with cancer. These cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. Understanding how these cells work may therefore help researchers to develop cancer treatments that starve tumors of their blood supply.
This research study involves an analysis of the behaviour of blood cells in response to different drugs in a test tube. The goal is to develop tests that can then be used to monitor patients treated with drugs that target blood vessel growth.
- Conditions
- Advanced Cancer, Healthy
- Keywords
- advanced cancer, healthy, blood sample, TEM, TIE-2 expressing monocytes, ANG1, ANG2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Cancer | Patients with histologically confirmed metastatic or unresectable solid tumors will have one tube of whole blood (~6mL) collected at the time of venipuncture for routine sample collection. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis. | |
| Healthy Volunteers | Eligible volunteers will have one tube of whole blood (~6mL) collected. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the in vitro response of circulating myeloid cells to angiopoeitins-1 and 2 (ANG1 and 2) in the presence or absence of pharmacologic inhibitors
This is an observational correlative laboratory protocol in which one tube of blood from healthy volunteers and cancer patients will be collected to perform in vitro stimulation of TEMs with ANG1 and 2 and flow cytometry analysis, which could serve as a biomarker for future ANG directed therapies. The results of this study will contribute to an improved understanding of ANG-TIE2 signaling in TEMs. Furthermore, this study will contribute directly to the development and optimization of protocols that will be applied a separate Phase I NCI trial of AMG 386 and temsirolimus.
Measured: 1 year
Secondary outcomes (1)
Develop and optimize flow cytometry analyses
This will comprise correlative studies in a separate upcoming Phase I clinical trial.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543841
- Sponsor's protocol ID
- TEMs-DC-001
- Status last verified
- Feb 2019
- First submitted
- 19 Jan 2012
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Evaluation of Tie-2 Expressing Monocytes (TEMs) in Healthy Volunteers and Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01543841
- Acronym / sponsor ID
- TEMs-DC-001
- Conditions
- Advanced Cancer, Healthy
- Keywords
- advanced cancer, healthy, blood sample, TEM, TIE-2 expressing monocytes, ANG1, ANG2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Mar 2012 (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.
Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in healthy individuals and in people with cancer. These cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. Understanding how these cells work may therefore help researchers to develop cancer treatments that starve tumors of their blood supply.
This research study involves an analysis of the behaviour of blood cells in response to different drugs in a test tube. The goal is to develop tests that can then be used to monitor patients treated with drugs that target blood vessel growth.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Cancer | – | –Patients with histologically confirmed metastatic or unresectable solid tumors will have one tube of whole blood (~6mL) collected at the time of venipuncture for routine sample collection. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis. |
| Healthy Volunteers | – | –Eligible volunteers will have one tube of whole blood (~6mL) collected. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced cancer attending the Phase I clinic and healthy staff at the Princess Margaret Hospital
Key inclusion criteria (5 listed)
- Healthy volunteers
- Patients with advancer cancer
Key exclusion criteria (6 listed)
- Healthy volunteers
- Patients with advancer cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize the in vitro response of circulating myeloid cells to angiopoeitins-1 and 2 (ANG1 and 2) in the presence or absence of pharmacologic inhibitors
Time frame: 1 year
This is an observational correlative laboratory protocol in which one tube of blood from healthy volunteers and cancer patients will be collected to perform in vitro stimulation of TEMs with ANG1 and 2 and flow cytometry analysis, which could serve as a biomarker for future ANG directed therapies. The results of this study will contribute to an improved understanding of ANG-TIE2 signaling in TEMs. Furthermore, this study will contribute directly to the development and optimization of protocols that will be applied a separate Phase I NCI trial of AMG 386 and temsirolimus.
1 secondary outcome
Develop and optimize flow cytometry analyses
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Lillian Siu, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Healthy, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 15 Feb 2019. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the in vitro response of circulating myeloid cells to angiopoeitins-1 and 2 (ANG1 and 2) in the presence or absence of pharmacologic inhibitors (time frame: 1 year). 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 15 Feb 2019.