Identification of Key Blood Molecular Markers for Immunotherapy
This study has suspended participant recruitment.
(Improving assay methods)
Sponsor:
Stanford University
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
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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 |
Resource links provided by NLM:
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:
- Patients diagnosed with cancerous tumors based on biopsy or other clinical observations.
- Patients diagnosed with non-cancerous tumors based on biopsy or other clinical observations.
- Normal volunteers who do not have cancer or other medical conditions that may affect survival.
Exclusion Criteria:
- 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.
- 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.
- 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
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 Adenocarcinoma, Mucinous Neoplasms Carcinoma Carcinoma, Squamous Cell |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on May 23, 2013