Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01546363

Enrollment

Registered

2012-03-07

Start date

2012-02-24

Completion date

2020-06-29

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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.

Interventions

OTHERBlood draw

phlebotomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Biomarkers (genes and proteins) of lymph node involvement	4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026