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Identification of Key Blood Molecular Markers for Immunotherapy

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ClinicalTrials.gov Identifier: NCT00507702
Recruitment Status : Suspended (Improving assay methods)
First Posted : July 26, 2007
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
To identify unique blood markers in cancer patients so that we can identify patients with evidence of pre-existing immunity who may be a responder to immunotherapy.

Condition or disease Intervention/treatment
Squamous Cell Carcinoma Adenocarcinoma Neoplasms Procedure: phlebotomy

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Key Blood Molecular Markers for Immunotherapy
Study Start Date : July 2006
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012
Groups and Cohorts
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Intervention Details:
    Procedure: phlebotomy
    Standard of care
    Other Name: blood draw

Outcome Measures
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Primary Outcome Measures :
  1. To identify and evaluate the presence of pre-existing immunity related markers in peripheral human blood, to identify patients who may respond to IL-12 immunotherapy [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tumors occur predominantly in the adult population after age 30, regardless of gender and ethnic background. Therefore, our study population will consist mainly of adult subjects. We do not have any exclusion criteria based on age range, gender or ethnic background.
Criteria

Inclusion Criteria:

  1. Patients diagnosed with cancerous tumors based on biopsy or other clinical observations.
  2. Patients diagnosed with non-cancerous tumors based on biopsy or other clinical observations.
  3. Normal volunteers who do not have cancer or other medical conditions that may affect survival.

Exclusion Criteria:

  1. Patients will be excluded if, upon clinical observation, they are under a severe septic or inflammatory condition. In these conditions, human body immune response against sepsis or inflammation should be the predominant response, and may shield or block the immune response against tumors.
  2. Patients will be excluded if, upon clinical observation, they are under extremely illness situation like myocardial infarction. In such a case, the immune findings may be altered.
  3. Patients will be excluded if, upon looking through their medical records, significant information required for data analysis is missing. This is because that patients' medical records will help us connect our research findings with their clinical observations, and further provide guidelines for subsequent treatment options.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507702


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jeffrey A. Norton Stanford University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00507702     History of Changes
Other Study ID Numbers: VAR0017
97125 ( Other Identifier: Stanford University Alternate IRB Approval Number )
VAR0017 ( Other Identifier: Stanford University )
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

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