Study of Blood Immune Cells in Cancer Patients Compared to Controls

Solid Carcinoma Clinical Trial

Official title:

Observational Immunomonitoring Study of NK/T and Myelocites Status in Cancer Patients and Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01312701
• Other study ID #: zeta-im-1
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2011
• Last updated: March 9, 2011
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2011
• Source: Hadassah Medical Organization
• Contact: Hovav Nechushtan, MD PHD
• Phone: 972 508946057
• Email: HOVAVNECH[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Solid Carcinoma

Locations

Country	Name	City	State
Israel	Oncology day care Oncology Dept Sharett Inst Hadassah Ein Kerem	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No