Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

NCT01546363 | Completed DMC

• 3 other identifiers: GYNCVX0002SU-03012012-920823080
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Biomarkers (genes and proteins) of lymph node involvement

  4 years

Study Arms (2)

Validation

Other: Blood draw

Testing

Other: Blood draw

Interventions

Blood draw OTHER

phlebotomy

Testing; Validation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• \- Pregnant women

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Tissue

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Elizabeth Kidd, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 7, 2012
• Study Start: February 24, 2012
• Primary Completion: September 1, 2019
• Study Completion: June 29, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)