Biomarkers in Women at High Risk for Developing Cervical Cancer - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00558389

Purpose

RATIONALE: Studying the genes expressed in samples of blood and cervix tissue from patients with a cervical abnormality may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biomarkers in women at high risk for developing cervical cancer.

Condition	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Procedure: biologic sample preservation procedure Procedure: colposcopic biopsy Procedure: diagnostic imaging Procedure: medical chart review Procedure: questionnaire administration

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	A Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Biomarkers for cervical cancer [ Designated as safety issue: No ]
Risk biomarkers [ Designated as safety issue: No ]
Gene expression profiles [ Designated as safety issue: No ]
Relationship between biomarkers and progression or nonprogression [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	September 2003

Detailed Description:

OBJECTIVES:

Assess biomarkers of risk for progressive cervical neoplasia that can distinguish patients at highest risk for cervical cancers from patients with benign infection.
Develop a comprehensive list of potential risk biomarkers by examining cervical tissues of women with normal, human papilloma virus (HPV) infection, precancer, and cancer.
Measure gene expression profiles to gain an accurate and comprehensive in vivo picture of cervical neoplasia carcinogenesis.
Assess the predictive values of candidate biomarkers for key outcomes related to progression (i.e., HPV persistence, diagnosis of precancer) or nonprogression (i.e., HPV clearance).

OUTLINE: Patients complete a questionnaire on health-related issues, undergo blood collection and cervix tissue collection along with biopsy for research purposes, and have photographs of the cervix taken. Cells and secretions from the cervix are also collected and tested for human papilloma virus infection. The procedure lasts approximately 1 hour.

Information about patients' health and medical records is stored in a data repository.

Patients are followed within 6 weeks after completion of the initial study visit and periodically thereafter for up to 5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Abnormal result on most recent pap smear
Must have been considered for any of the following cervical procedures by a physician:
- Colposcopy
- Cervical biopsy
- Treatment of a cervical abnormality
- Hysterectomy

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558389

Locations

United States, Oklahoma
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Contact Person 301-402-5347

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Sophia S. Wang

National Cancer Institute (NCI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Dunn ST, Allen RA, Wang S, Walker J, Schiffman M. DNA extraction: an understudied and important aspect of HPV genotyping using PCR-based methods. J Virol Methods. 2007 Jul;143(1):45-54. Epub 2007 Mar 30.

Wang SS, Dasgupta A, Sherman ME, Walker JL, Gold MA, Zuna R, Sakoda L, Wacholder S, Schiffman M, Baker CC. Towards improved biomarker studies of cervical neoplasia: effects of precolposcopic procedures on gene expression patterns. Diagn Mol Pathol. 2005 Jun;14(2):59-64.

Study ID Numbers:	CDR0000555665, NCI-03-C-N302
Study First Received:	November 14, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00558389
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical cancer
human papilloma virus infection

Study placed in the following topic categories:

Virus Diseases
Precancerous Conditions
Papillomavirus Infections
Papilloma

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009