Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01546363
First received: March 1, 2012
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Cervical Cancer
Other: Blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Biomarkers (genes and proteins) of lymph node involvement [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood Tissue


Estimated Enrollment: 100
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)
Groups/Cohorts Assigned Interventions
Validation Other: Blood draw
phlebotomy
Testing Other: Blood draw
phlebotomy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546363

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Alice Banh    650-723-1423    aliceb@stanford.edu   
Sub-Investigator: Albert Koong, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Elizabeth Kidd, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01546363     History of Changes
Other Study ID Numbers: GYNCVX0002, SU-03012012-9208, 23080
Study First Received: March 1, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014