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Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

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ClinicalTrials.gov Identifier: NCT00349830
Recruitment Status : Recruiting
First Posted : July 10, 2006
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Carcinomas (Including Squamous Cell and Adenocarcinoma) Neoplasms Procedure: blood draw

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
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy
Study Start Date : January 2002
Estimated Primary Completion Date : January 2032
Estimated Study Completion Date : January 2032
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Biomarkers for disease [ Time Frame: Day one ]

Biospecimen Retention:   Samples Without DNA
blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
cancer patients
Criteria
  1. Age > or = 18; for the samples collected under the NIH grant, no subjects below the age of 20 will be enrolled.
  2. Prior diagnosis of cancer or suspected of having cancer
  3. Karnofsky performance status of greater than 70
  4. Standard pretreatment evaluation
  5. Signed Stanford University Human Subjects Committee consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349830


Contacts
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Contact: Rene Bonilla 650-498-7703 rbonilla@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Rene Bonilla    650-498-7703    rbonilla@stanford.edu   
Principal Investigator: Maximilian Diehn         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Maximilian Diehn Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00349830    
Other Study ID Numbers: IRB-13535
77923 ( Other Identifier: Stanford University Alternate IRB Approval Number )
IRB-13535 ( Other Identifier: Stanford IRB )
VAR0006 ( Other Identifier: OnCore )
5R01CA18829804 ( Other Grant/Funding Number: NIH )
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms