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Identification of Key Blood Molecular Markers for Immunotherapy

This study has suspended participant recruitment.
(Improving assay methods)
Information provided by (Responsible Party):
Stanford University Identifier:
First received: July 24, 2007
Last updated: July 5, 2012
Last verified: July 2012
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 Intervention
Squamous Cell Carcinoma
Procedure: phlebotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Key Blood Molecular Markers for Immunotherapy

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: July 2006
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: phlebotomy
    Standard of care
    Other Name: blood draw

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.

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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Please refer to this study by its identifier: NCT00507702

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Jeffrey A. Norton Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT00507702     History of Changes
Other Study ID Numbers: VAR0017
97125 ( Other Identifier: Stanford University Alternate IRB Approval Number )
VAR0017 ( Other Identifier: Stanford University )
Study First Received: July 24, 2007
Last Updated: July 5, 2012

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell processed this record on May 23, 2017