Clinical trial NCT01312701: Study of Blood Immune Cells in Cancer Patients Compared to Controls
Official title: Observational Immunomonitoring Study of NK/T and Myelocites Status in Cancer Patients and Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Carcinoma
Keywords: cancer
immunomonitoring
CD247 -zeta chain
chronic inflamation
anticancertherapy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2011-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: controls - patients who were deemed eligible for blood donation cancer patients - patients with solid tumors who agreed to participate in the study

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* patients with cancer or blood donators agreeing to participate in the trial

Exclusion Criteria:

* other disease states which may cause chronic inflammation

Primary outcomes:
measure: changes in immune markers mainly cd247-zeta chain - levels in cancer patients undergoing therapy
timeFrame: 4-2013 24 month
measure: levels of zeta chain -cd247 in cancer patients
timeFrame: till begining of 2013 ( putative)
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Oncology day care Oncology Dept Sharett Inst Hadassah Ein Kerem
Study officials:
affiliation: Oncology Dept Hadassah Hebrew University Medical Center
name: Hovav Nechushtan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.