Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Completed

• Conditions: Cervical Cancer
• Interventions: Other: Blood draw

• Registration Number: NCT01546363
• Lead Sponsor: Stanford University

Brief 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.

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.

Study Timeline

• Study Start: 2012-02-24
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Primary Completion: 2019-09-01
• Study Completion: 2020-06-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

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Exclusion Criteria

• Pregnant women

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Testing	Blood draw	-
Validation	Blood draw	-

Primary Outcome Measures

Name	Time	Method
Biomarkers (genes and proteins) of lymph node involvement	4 years

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States