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Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

This study is currently recruiting participants.
Verified May 2017 by Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546363
First Posted: March 7, 2012
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  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 ]

Biospecimen Retention:   Samples With DNA
Blood Tissue

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: January 1, 2019
Estimated Primary Completion Date: January 1, 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546363


Contacts
Contact: Dylann Fujimoto 650-723-8843 dylannf@stanford.edu

Locations
United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Dylann Fujimoto    650-723-8843    dylannf@stanford.edu   
Sub-Investigator: Albert Koong, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Elizabeth Kidd, MD Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01546363     History of Changes
Other Study ID Numbers: GYNCVX0002
SU-03012012-9208 ( Other Identifier: Stanford University )
23080 ( Other Identifier: Stanford IRB )
First Submitted: March 1, 2012
First Posted: March 7, 2012
Last Update Posted: May 9, 2017
Last Verified: May 2017

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