Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01546363
First received: March 1, 2012
Last updated: August 11, 2014
Last verified: August 2014

March 1, 2012
August 11, 2014
February 2012
December 2016   (final data collection date for primary outcome measure)
Biomarkers (genes and proteins) of lymph node involvement [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01546363 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood Tissue

Non-Probability Sample

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.

Cervical Cancer
Other: Blood draw
phlebotomy
  • Validation
    Intervention: Other: Blood draw
  • Testing
    Intervention: Other: Blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2016
December 2016   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Jacob Wynne 650-723-8843 jwynne@stanford.edu
United States
 
NCT01546363
GYNCVX0002, SU-03012012-9208, 23080
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Elizabeth Kidd, MD Stanford University
Stanford University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP