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
  Purpose

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
Adenocarcinoma
Neoplasms
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 ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00507702     History of Changes
Other Study ID Numbers: VAR0017, 97125, VAR0017
Study First Received: July 24, 2007
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014