Identification of Key Blood Molecular Markers for Immunotherapy

April 16, 2019 updated by: Stanford University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2006

Primary Completion (ACTUAL)

February 25, 2015

Study Completion (ACTUAL)

February 25, 2015

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (ESTIMATE)

July 26, 2007

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAR0017 (OTHER: Stanford University)
  • 97125 (OTHER: Stanford University Alternate IRB Approval Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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