NCT01074424

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment. PURPOSE: This research study is looking at biomarkers in blood samples from patients with invasive cervical cancer.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

28 days

First QC Date

February 23, 2010

Last Update Submit

February 23, 2010

Conditions

Cervical Cancer

Keywords

stage IIB cervical cancerstage III cervical cancerstage IVA cervical cancercervical adenocarcinomacervical adenosquamous cell carcinomacervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Generation of a serum proteomic profile using banked pre-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and progression-free survival [PFS])

Secondary Outcomes (1)

  • Generation of a serum proteomic profile using banked post-treatment serum specimens that may have potential utility for cervical cancer prognosis (overall survival and PFS)

Interventions

proteomic profilingGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix * Stage IIB, III, or IVA disease * Eligible and evaluable for GOG-0191 * Pre- and/or post-treatment serum specimens available for proteomic analysis PATIENT CHARACTERISTICS: * Patient has given consent to allow their specimen(s) to be used for future cancer research PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Samir N. Khleif, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Last Updated

February 24, 2010

Record last verified: 2010-02