Identification of Key Blood Molecular Markers for Immunotherapy

This study has suspended participant recruitment.
(Improving assay methods)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00507702
First received: July 24, 2007
Last updated: July 5, 2012
Last verified: July 2012

July 24, 2007
July 5, 2012
July 2006
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00507702 on ClinicalTrials.gov Archive Site
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Identification of Key Blood Molecular Markers for Immunotherapy
Identification of Key Blood Molecular Markers for Immunotherapy

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Squamous Cell Carcinoma
  • Adenocarcinoma
  • Neoplasms
Procedure: phlebotomy
Standard of care
Other Name: blood draw
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
300
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507702
VAR0017, 97125, VAR0017
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Jeffrey A. Norton Stanford University
Stanford University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP