Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00349830
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Duration (Months): 360
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated 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: Jan 1, 2002
• Anticipated Primary Completion Date: Jan 1, 2032
• Anticipated Study Completion Date: Jan 1, 2032

Outcome Measures

Primary Outcome Measures

1. Biomarkers for disease [Day one]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Maximilian Diehn, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT00349830
• Other Study ID Numbers: IRB-13535; 77923; IRB-13535; VAR0006; 5R01CA18829804
• First Posted: Jul 10, 2006
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Mar 17, 2022