Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00349830
First received: July 5, 2006
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to measure the levels of serum proteins and other biomarkers in cancer patients and in patients suspected of having cancer. We believe that some of these markers may be useful for confirming the diagnosis or for selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Survival analysis and response to anti-cancer therapy [ Time Frame: At each follow-up (3 months, 6 months, 1 year; at discretion of MD) 2- Safety Issue?- No ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 500
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
Sampling Method:   Non-Probability Sample
Study Population

cancer patients healthy controls

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
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: NCT00349830

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Justin Bui    650-498-7703    jlbui@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Albert Koong         
Sub-Investigator: James M Ford         
Sub-Investigator: Quynh-Thu Le         
Sub-Investigator: George Albert Fisher M.D. Ph.D.         
Sub-Investigator: Anson W Lowe         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Albert Koong Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00349830     History of Changes
Other Study ID Numbers: VAR0006, 77923
Study First Received: July 5, 2006
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014