Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer
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Purpose
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.
| 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 |
- Biomarkers (genes and proteins) of lymph node involvement [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood Tissue
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Validation |
Other: Blood draw
phlebotomy
|
| Testing |
Other: Blood draw
phlebotomy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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 have undergone a standard-of-care biopsy of the cervical tumor to provide tissue for the study.
- Patients must be willing to give a blood sample to provide plasma for the study.
- Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes.
- Patients must be pre-treatment.
Exclusion Criteria:
- Pregnant women
Contacts and Locations| Contact: Jacob Wynne | 650-723-8843 | jwynne@stanford.edu |
| United States, California | |
| Stanford University Cancer Institute | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Stanford Cancer Clinical Trials Office | |
| Sub-Investigator: Albert Koong, MD | |
| Principal Investigator: | Elizabeth Kidd, MD | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01546363 History of Changes |
| Other Study ID Numbers: | GYNCVX0002, SU-03012012-9208, 23080 |
| Study First Received: | March 1, 2012 |
| Last Updated: | May 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on June 17, 2013