Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546363
• Other study ID #: GYNCVX0002
• Secondary ID: SU-03012012-9208
• Status: Completed
• Start date: February 24, 2012
• Est. completion date: June 29, 2020

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 29, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Blood draw
phlebotomy

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers (genes and proteins) of lymph node involvement		4 years