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


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Christine Holschneider, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

99-10-034

NCT ID:

NCT00039312

Start Date:

December 1999

Completion Date:

April 2010

Related Keywords:

  • Cervical Cancer
  • cervical cancer
  • Neoplasms
  • Uterine Cervical Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781