Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

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.

Recruitment of patients for participation in this study will occur at Stanford Medical Center. All facilities are adequately equipped to meet all study requirements. Patients of this disease type are regularly treated at Stanford Cancer Center. Estimated accrual rates are based on normal patient flow.

• Validation
  Intervention: Other: Blood draw
• Testing
  Intervention: Other: Blood draw

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 have undergone a standard-of-care biopsy of the cervical tumor to provide tissue for the study.
• Patients must be willing to give a blood sample to provide plasma for the study.
• Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes.
• Patients must be pre-treatment.

Exclusion Criteria:

- Pregnant women