Comparison of Screening Tests in Detecting Cervical Neoplasia

• Sponsor: Jonsson Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00039312
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Duration (Months): 124
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Other: Papanicolaou test; Other: cytology specimen collection procedure; Procedure: annual screening; Procedure: colposcopic biopsy; Procedure: comparison of screening methods	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Primary Purpose: Screening
• Official Title: Multi-Institutional Prospective Cohort Study For The Comparison Of Different Primary Screening Strategies For The Detection Of Cervical Neoplasia
• Study Start Date: Dec 1, 1999
• Actual Primary Completion Date: Aug 1, 2003
• Actual Study Completion Date: Apr 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781

Sponsors and Collaborators

• Jonsson Comprehensive Cancer Center

Investigators

• Study Chair: Christine Holschneider, MD, Jonsson Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00039312
• Other Study ID Numbers: 99-10-034; UCLA-9910034; NCI-G02-2076
• First Posted: Jan 27, 2003
• Last Update Posted: Aug 3, 2020
• Last Verified: Jul 1, 2012

• Keywords provided by Jonsson Comprehensive Cancer Center: cervical cancer
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Aug 3, 2020