Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

This study is currently recruiting participants.

Verified by Stanford University, May 2009

First Received: July 5, 2006 Last Updated: May 8, 2009 History of Changes

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00349830

Purpose

The purpose of this trial is to collect blood serum from cancer patients with tumors at different disease sites (such as pancreas, head and neck, and breast) prior to and at subsequent points following anti-cancer therapy to discover novel serum markers of response.

Condition	Intervention
Carcinomas (Including Squamous Cell and Adenocarcinoma)	Procedure: blood draw

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Development of Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Survival analysis and response to anti-cancer therapy

Estimated Enrollment:	300
Study Start Date:	January 2002
Estimated Primary Completion Date:	January 2022 (Final data collection date for primary outcome measure)

Detailed Description:

This is a blood serum collection study at Stanford University for patients with cancer at a variety of disease sites. The purpose of this study is to collect and store blood serum from patients before, during, and after anti-cancer therapy to find new biomarkers that signal disease or response to anti-cancer therapy. The collection and analysis of these biomarkers may lead to improved diagnostic and treatment therapies for certain cancers in the future. We are also interested in collecting blood serum from healthy individuals such as the spouses, relatives, and friends of cancer patients to obtain healthy controls for comparison

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:- Over age 18, no maximum age limit

Prior diagnosis of cancer (unless healthy control)
Karnofsky performance status of greater than 70
Standard pre-treatment evaluation
Negative pregnancy test
Signed informed consent

Exclusion Criteria:- Less than 18 years old

Patient without cancer (unless healthy control)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349830

Contacts

Contact: Jeff Kim

(650) 498-7703

jeff.kim@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Jeff Kim 650-498-7703 jeff.kim@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Albert Koong
Sub-Investigator: Anson W Lowe
Sub-Investigator: Quynh-Thu Le
Sub-Investigator: James M Ford
Sub-Investigator: George Albert Fisher M.D. Ph.D.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Albert Koong

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Albert Koong, Principal Investigator )
Study ID Numbers:	VAR0006, 77923, NCT00349830, VAR0006
Study First Received:	July 5, 2006
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00349830 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009