Expired Study
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Oklahoma City, Oklahoma 73104


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000555665


NCT ID:

NCT00558389


Secondary ID:

NCI-03-C-N302


Study Acronym:


Brief Title:

Biomarkers in Women at High Risk for Developing Cervical Cancer


Official Title:

A Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED)


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Diagnostic


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

2000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Sophia S. Wang
Principal Investigator
National Cancer Institute (NCI)

Study Dates

Start Date:September 2003
Verification Date:October 2008
Last Changed Date:January 27, 2010
First Received Date:November 14, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Relationship between biomarkers and progression or nonprogression
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Gene expression profiles
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Risk biomarkers
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Biomarkers for cervical cancer
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:biologic sample preservation procedure
Intervention Type:Other
Name:medical chart review
Intervention Type:Other
Name:questionnaire administration
Intervention Type:Procedure
Name:colposcopic biopsy
Intervention Type:Procedure
Name:diagnostic imaging

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:17399803
Reference Type:Reference
Citation: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.
PMID:15905687

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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