Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Study Phase
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Name: Blood draw
Type: Other
Overall Status
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.
Detailed Description

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Stanford University Cancer Institute
Stanford, California, United States
Status: Recruiting
Contact: Polly Young - 650-497-7499 - polly.young@stanford.edu
Start Date
February 2012
Completion Date
December 2016
Stanford University
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page