Study of Blood Immune Cells in Cancer Patients Compared to Controls

NCT01312701 | Unknown

• 1 other identifier: zeta-im-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Solid Carcinoma

Keywords

cancer; immunomonitoring; CD247 -zeta chain; chronic inflamation; anticancertherapy

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• other disease states which may cause chronic inflammation

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Oncology day care Oncology Dept Sharett Inst Hadassah Ein Kerem

Jerusalem, 91120, Israel

RECRUITING

Related 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. doi: 10.4049/jimmunol.177.7.4763.

  PMID: 16982917 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will collect peripheral blood for facts analysis of intracellular levels of proteins. Some of these cells may be frozen for longer periods of time for comparison with other new samples.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Hovav Nechushtan, MD PhD

  Oncology Dept Hadassah Hebrew University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hovav Nechushtan, MD PHD

CONTACT

972 508946057; HOVAVNECH@hadassah.org.il

Moshe sade, BSC

CONTACT

97226776750; moshe.sadefeldm@mail.huji.ac.il]

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 11, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 11, 2011

Record last verified: 2011-03

Locations

IL (1)