Solid CarcinomaNCT01312701
Study of Blood Immune Cells in Cancer Patients Compared to Controls
An observational study of Solid Carcinoma, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Tumors have a systemic immune modifying effect. They affect the immune system similarly to states of chronic inflammation and these effects can: be monitored through analysis of nk t and myeloid cells mainly through studies of the zeta chain but also through other means may be decreased following effective anticancer… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Carcinoma
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Dec 2013
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: controls - patients who were deemed eligible for blood donation cancer patients - patients with solid tumors who agreed to participate in the study
Who may be able to join
- patients with cancer or blood donators agreeing to participate in the trial
Who cannot join
- other disease states which may cause chronic inflammation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Oncology day care Oncology Dept Sharett Inst Hadassah Ein Kerem
Jerusalem, 91120
Tamar Hamburger, BA, 97226777745, Tamarh@hadassah.org.il
hovav nechushtan, md phd
About this study
Official title: Observational Immunomonitoring Study of NK/T and Myelocites Status in Cancer Patients and Controls
Tumors have a systemic immune modifying effect. They affect the immune system similarly to states of chronic inflammation and these effects can:
- be monitored through analysis of nk t and myeloid cells mainly through studies of the zeta chain but also through other means
- may be decreased following effective anticancer therapy - may even be used to study the effectiveness of anticancer therapy
- are important to monitor if the investigators plan on formulation of systemic immune therapy Thus immumonitoring of systemic blood cells may turn out to be an important prognostic and predictive factor in many cancer types
Read the detailed description
CD247 Known also as the zeta chain is important for relaying T-cell induced signal transduction.
Interestingly studies by Baniash and others have demonstrated that this chain is down regulated in states of chronic inflammation and cancer in peripheral blood T cells and also in NK cells However there has not been a prospective study of this marker in cancer and control patients such a study will reveal not only the levels of CD247 in immune cells of cancer patients compared to controls but may reveal the effect of anticancer therapies on CD247 in cancer patients such a study may contribute significantly to our ability to monitor systemic immune system characteristics in cancer patients and help in any further studies of immunomodulation such as vaccination schemes in such patients
- Conditions
- Solid Carcinoma
- Keywords
- cancer, immunomonitoring, CD247 -zeta chain, chronic inflamation, anticancertherapy
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| cancer patients | as described patietns with solid cancer about to be treated with anticancer therapies | |
| control group | normal populations who domated blood for further use |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in immune markers mainly cd247-zeta chain - levels in cancer patients undergoing therapy
Hopefully by this time the investigators will be able to see if there are lower zeta chain intracellular expression levels in cancer patients and whether response to therapy enhances recovery of zeta chain
Measured: 4-2013 24 month
levels of zeta chain -cd247 in cancer patients
intracellular levels of cd247 compared to other intracellular proteins and other markers of immune response will be monitored in patients with cancer and a control group in cancer patients the investigators will conduct several tests to analyze effects of therapy
Measured: till begining of 2013 ( putative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid CarcinomaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- Hovav Nechushtan, MD PhD, Principal investigator, Oncology Dept Hadassah Hebrew University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312701
- Sponsor's protocol ID
- zeta-im-1
- Status last verified
- Mar 2011
- First submitted
- 1 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ezernitchi AV, Vaknin I, Cohen-Daniel L, Levy O, Manaster E, Halabi A, Pikarsky E, Shapira L, Baniyash M. TCR zeta down-regulation under chronic inflammation is mediated by myeloid suppressor cells differentially distributed between various lymphatic organs. J Immunol. 2006 Oct 1;177(7):4763-72. doi: 10.4049/jimmunol.177.7.4763.
PubMed 16982917
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Immunomonitoring Study of NK/T and Myelocites Status in Cancer Patients and Controls
- ClinicalTrials.gov ID
- NCT01312701
- Acronym / sponsor ID
- zeta-im-1
- Conditions
- Solid Carcinoma
- Keywords
- cancer, immunomonitoring, CD247 -zeta chain, chronic inflamation, anticancertherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Mar 2011 (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.
Tumors have a systemic immune modifying effect. They affect the immune system similarly to states of chronic inflammation and these effects can:
- be monitored through analysis of nk t and myeloid cells mainly through studies of the zeta chain but also through other means
- may be decreased following effective anticancer therapy - may even be used to study the effectiveness of anticancer therapy
- are important to monitor if the investigators plan on formulation of systemic immune therapy Thus immumonitoring of systemic blood cells may turn out to be an important prognostic and predictive factor in many cancer types
Detailed description
CD247 Known also as the zeta chain is important for relaying T-cell induced signal transduction.
Interestingly studies by Baniash and others have demonstrated that this chain is down regulated in states of chronic inflammation and cancer in peripheral blood T cells and also in NK cells However there has not been a prospective study of this marker in cancer and control patients such a study will reveal not only the levels of CD247 in immune cells of cancer patients compared to controls but may reveal the effect of anticancer therapies on CD247 in cancer patients such a study may contribute significantly to our ability to monitor systemic immune system characteristics in cancer patients and help in any further studies of immunomodulation such as vaccination schemes in such patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer patients | – | –as described patietns with solid cancer about to be treated with anticancer therapies |
| control group | – | –normal populations who domated blood for further use |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- controls - patients who were deemed eligible for blood donation cancer patients - patients with solid tumors who agreed to participate in the study
Key inclusion criteria (1 listed)
- patients with cancer or blood donators agreeing to participate in the trial
Key exclusion criteria (1 listed)
- other disease states which may cause chronic inflammation
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
changes in immune markers mainly cd247-zeta chain - levels in cancer patients undergoing therapy
Time frame: 4-2013 24 month
Hopefully by this time the investigators will be able to see if there are lower zeta chain intracellular expression levels in cancer patients and whether response to therapy enhances recovery of zeta chain
levels of zeta chain -cd247 in cancer patients
Time frame: till begining of 2013 ( putative)
intracellular levels of cd247 compared to other intracellular proteins and other markers of immune response will be monitored in patients with cancer and a control group in cancer patients the investigators will conduct several tests to analyze effects of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
- Background: PubMed 16982917Ezernitchi AV, Vaknin I, Cohen-Daniel L, Levy O, Manaster E, Halabi A, Pikarsky E, Shapira L, Baniyash M. TCR zeta down-regulation under chronic inflammation is mediated by myeloid suppressor cells differentially distributed between various lymphatic organs. J Immunol. 2006 Oct 1;177(7):4763-72. doi: 10.4049/jimmunol.177.7.4763.
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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.
Hovav Nechushtan, MD PhD principal investigator
Oncology Dept Hadassah Hebrew University Medical Center
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 Solid Carcinoma, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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 11 Mar 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hovav Nechushtan, MD PHD (972 508946057, HOVAVNECH@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in immune markers mainly cd247-zeta chain - levels in cancer patients undergoing therapy (time frame: 4-2013 24 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312701, which also lists 1 linked publication.
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 11 Mar 2011.