Post Colposcopy Management of ASC-US and LSIL Pap Tests

Summary

There is weak evidence supporting optimal follow-up of women with ASC-US or LSIL cytology found to have low grade disease or normal findings at initial colposcopy. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. The investigators performed a pilot randomized controlled trial (RCT) comparing these 3 follow-up policies. Study objectives are to determine the feasibility of an RCT and to compare the incidence of \>/=HSIL in each of the arms by intention to treat principle.

Conditions

• Cervical Cancer Screening

Interventions

PROCEDURE

Colposcopy

Women will undergo colposcopy at 6 and 12 months after randomization. Those with CIN II will be managed according to standard of care. Those with CIN 1 6 months post randomization will have a second exam 6 months later and if still CIN I will have an exit colposcopy 6 months later. All women in the Pap and HPV testing policies as well as all women in the colposcopy policy with CIN 1 after 2 exams will have an exit colposcopy 18 months after randomization. The exit colposcopy is a safeguard against the possibility of any false negatives in the follow up policies. The exit colposcopy will also establish the true numbers of CIN lesions in the 3 policies in order to determine their sensitivities and specificities. At the exit colposcopy,all will have an endocervical curettage,and either a minimum of 2 directed biopsies of any mucosal abnormality or in the event no abnormality is identified,2 random biopsies from the cervix.

OTHER

Pap test

Women will receive Pap tests at 6 and 12 months after randomization. The Pap test will be prepared using the Thinprep® system which is the standard at Calgary Laboratory Services. Women with a Pap test result of malignant, HSIL, AIS, AGC, ASC-H, or LSIL-H (\>LSIL) at 6 or 12 months post randomization will be referred for colposcopic examination. Women with an ASC-US or LSIL result (\</=LSIL) will have a second follow up Pap test 6 months later (12 months post randomization). Those with a persistent result of ASC-US or LSIL or \>LSIL at 6 or 12 months will be referred for colposcopic examination. Outcome in the Pap policy is positive when the histopathology is \>/=CIN II. Results of \</=CIN I equal a negative outcome. All other Pap test results will have an exit colposcopy 6 months later (18 months post randomization).

DIAGNOSTIC_TEST

HPV test

Women will have an HPV test performed on a cervical scrape sample 12 months after randomization. Women with a positive result will be referred for colposcopy. Outcome in the HPV testing policy is positive when histopathology obtained at the colposcopic exam shows CIN II. All other results equal a negative outcome. HPV negative women will have an exit colposcopy 18 months post randomization. HPV testing will be performed using Cervista™HPV HR(Third Wave Technologies Inc./Hologic Inc, Madison, WI, USA).This HPV DNA test identifies 14 high risk types (16,18,31,33,35,39,45,51,52,56,58,59,66,68). Testing will be performed on the residual cervical scrape sample which is fixed in the PreservCyt® solution of the Thinprep® liquid based system(Hologic Inc, Marlborough, Ma, USA). Cervical samples may be held for up to 24 wks at room temperature before DNA extraction.This allows time for transportation without refrigeration.The samples will be sent by overnight express delivery to the laboratory.

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Principal Investigators

• Gregg Nelson, MD, FRCSC, PhD · Tom Baker Cancer Centre, University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2012-08-31

Completion

2012-08-31