Study of Blood Immune Cells in Cancer Patients Compared to Controls

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

Study Overview

• Status: Unknown
• Conditions: Solid Carcinoma

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Hovav Nechushtan, MD PHD; Phone Number: 972 508946057; Email: HOVAVNECH@hadassah.org.il
• Study Contact Backup: Name: Moshe sade, BSC; Phone Number: 2 97226776750; Email: moshe.sadefeldm@mail.huji.ac.il]

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Oncology day care Oncology Dept Sharett Inst Hadassah Ein Kerem
    • Contact: Tamar Hamburger, BA; Phone Number: 97226777745; Email: Tamarh@hadassah.org.il
    • Principal Investigator: hovav nechushtan, md phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• other disease states which may cause chronic inflammation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	till begining of 2013 ( putative)

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Hebrew University of Jerusalem
• Investigators: Principal Investigator: Hovav Nechushtan, MD PhD, Oncology Dept Hadassah Hebrew University Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 11, 2011

Study Record Updates

• Last Update Posted (Estimate): March 11, 2011
• Last Update Submitted That Met QC Criteria: March 9, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: cancer; immunomonitoring; CD247 -zeta chain; chronic inflamation; anticancertherapy
• Other Study ID Numbers: zeta-im-1