Identification of Key Blood Molecular Markers for Immunotherapy

NCT00507702 | Terminated DMC

• 2 other identifiers: VAR001797125
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinoma; Adenocarcinoma; Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Interventions

phlebotomy PROCEDURE

Standard of care

Also known as: blood draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Adenocarcinoma; Neoplasms

Interventions

Phlebotomy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeffrey A. Norton

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 26, 2007
• Study Start: July 6, 2006
• Primary Completion: February 25, 2015
• Study Completion: February 25, 2015
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)