Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer
The purpose of this study is to measure the levels of serum proteins and other biomarkers in cervical cancer patients. We believe that some of these markers may be useful in 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer|
- Biomarkers (genes and proteins) of lymph node involvement [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Other: Blood draw
Other: Blood draw
SPECIFIC STUDY AIMS
Specific Aim 1: To use gene expression analysis of primary cervical cancers to identify a gene expression signature that predicts for lymph node metastases in this disease.
Specific Aim 2: To predict lymph node metastases by performing multiplex measurements of cancer-associated proteins and cytokines using proximity ligation assay (PLA) on plasma samples.
Specific Aim 3: To measure circulating human papilloma virus (HPV) DNA in the plasma samples of cervical cancer patients using real-time quantitative polymerase chain reaction (qPCR) and determine its ability to predict for nodal metastases.
Specific Aim 4: To use deep sequencing to evaluate gene and sequence differences between cervical cancer patients with and without lymph node metastasis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546363
|United States, California|
|Stanford University Cancer Institute||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Polly Young 650-497-7499 email@example.com|
|Sub-Investigator: Albert Koong, MD|
|Principal Investigator:||Elizabeth Kidd, MD||Stanford University|