Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer
NCT ID: NCT01546363
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
95 participants
OBSERVATIONAL
2012-02-24
2020-06-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Validation
Blood draw
phlebotomy
Testing
Blood draw
phlebotomy
Interventions
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Blood draw
phlebotomy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Kidd, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University, School of Medicine
Stanford, California, United States
Countries
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Other Identifiers
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SU-03012012-9208
Identifier Type: OTHER
Identifier Source: secondary_id
23080
Identifier Type: OTHER
Identifier Source: secondary_id
GYNCVX0002
Identifier Type: -
Identifier Source: org_study_id
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