Study of Blood Immune Cells in Cancer Patients Compared to Controls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01312701
First received: March 1, 2011
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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

Condition
Solid Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Immunomonitoring Study of NK/T and Myelocites Status in Cancer Patients and Controls

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • changes in immune markers mainly cd247-zeta chain - levels in cancer patients undergoing therapy [ Time Frame: 4-2013 24 month ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


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.


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312701

Contacts
Contact: Hovav Nechushtan, MD PHD 972 508946057 HOVAVNECH@hadassah.org.il
Contact: Moshe sade, BSC 97226776750 ext 2 moshe.sadefeldm@mail.huji.ac.il]

Locations
Israel
Oncology day care Oncology Dept Sharett Inst Hadassah Ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Tamar Hamburger, BA    97226777745    Tamarh@hadassah.org.il   
Principal Investigator: hovav nechushtan, md phd         
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
Investigators
Principal Investigator: Hovav Nechushtan, MD PhD Oncology Dept Hadassah Hebrew University Medical Center
  More Information

Publications:
Responsible Party: Hovav Nechushtan senior Lecturer MD PhD, Hadassah Hebrew University Medical center
ClinicalTrials.gov Identifier: NCT01312701     History of Changes
Other Study ID Numbers: zeta-im-1
Study First Received: March 1, 2011
Last Updated: March 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
cancer
immunomonitoring
CD247 -zeta chain
chronic inflamation
anticancertherapy

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014