Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer
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.
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.
Inclusion Criteria:

 -  Patients must have a known or suspected cervical cancer.

 -  Age >=18 years.

 -  Patients must have no other active cancer at the time of diagnosis.

 -  Patients must have no history of a hysterectomy.

 -  Patients must be able to give informed consent.

 -  Patients must be willing to undergo a biopsy of the cervical tumor to provide tissue
 for the study.

 -  Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of
 therapy, for assessment of lymph nodes.

 Exclusion Criteria:

 - Pregnant women