Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Screening tests may help doctors detect abnormal cells in the cervix early and plan effective treatment. PURPOSE: Screening trial to compare different types of screening tests used to detect cervical neoplasia.


Study summary:

OBJECTIVES: - Compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia. - Compare the positive and negative predictive values of these strategies. OUTLINE: This is a multicenter study. Patients are stratified according to the reason for the visit (general gynecological screening vs colposcopy referral). - Stratum 1 (general gynecological screening): Patients undergo Pap smear, visual inspection aided by acetic acid (VIA), a colposcopy, and finally a visual inspection aided by toluidine blue (VIT) followed by an acetic acid wash. A biopsy may be performed at this initial visit. Within 2-3 weeks, patients are notified of results. - Stratum 2 (colposcopy referral): Patients undergo Pap smear, VIA, colposcopy, VIT, and possible biopsy as in stratum 1. During the same visit, patients receive histologic evaluation and treatment with See-and-Treat loop electrosurgical excision procedure and/or endocervical curettage. PROJECTED ACCRUAL: A total of 600-1,000 patients (300-500 per stratum) will be accrued for this study.


Criteria:

Inclusion Criteria:: - History of cervical neoplasia - Presenting for a well-woman visit, annual Pap smear, or family planning - Other gynecological or non-gynecological complaints allowed OR - Referred for colposcopy secondary to an abnormal Pap smear - Planned screening for cervical cancer - Over 18 years of age - Prior laser surgery, cryotherapy, or conization or loop electrosurgical excision procedure for cervical neoplasia allowed Exclusion Criteria: - bleeding diathesis - pregnant - prior hysterectomy - concurrent anticoagulants


Study is Available At:


Original ID:

99-10-034


NCT ID:

NCT00039312


Secondary ID:

P30CA016042


Study Acronym:


Brief Title:

Comparison of Screening Tests in Detecting Cervical Neoplasia


Official Title:

Multi-Institutional Prospective Cohort Study For The Comparison Of Different Primary Screening Strategies For The Detection Of Cervical Neoplasia


Overall Status:

Completed


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:

Jonsson Comprehensive Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Screening


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Christine Holschneider, MD
Study Chair
Jonsson Comprehensive Cancer Center

Study Dates

Start Date:December 1999
Completion Date:April 2010
Completion Type:Actual
Primary Completion Date:August 2003
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 27, 2012
First Received Date:June 6, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Other
Name:Papanicolaou test
Intervention Type:Other
Name:cytology specimen collection procedure
Intervention Type:Procedure
Name:annual screening
Intervention Type:Procedure
Name:colposcopic biopsy
Intervention Type:Procedure
Name:comparison of screening methods

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Jonsson Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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