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Post Colposcopy Management of ASC-US and LSIL Pap Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03466710
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : May 2, 2018
Information provided by (Responsible Party):
University of Calgary

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Screening Procedure: Colposcopy Other: Pap test Diagnostic Test: HPV test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Post Colposcopy Management of ASC-US and LSIL Pap Tests (PALS Trial): Pilot Study
Actual Study Start Date : January 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Colposcopy arm
Patients received colposcopy as per standard of care
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.

Experimental: Pap arm
Patients received a Pap test only
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).

Experimental: HPV arm
Patients received an HPV test only
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.

Primary Outcome Measures :
  1. Adherence to study protocol [ Time Frame: 6 months ]
    Adherence will be defined as colposcopist performing the test the patient is randomized to and NOT performing a different test. Proportion of patients who had the correct test done over total number of patients being tested will be recorded.

  2. Patient recruitment rate [ Time Frame: 8 months ]
    Percentage of eligible patients will be calculated by counting the number of referrals to colposcopy with eligible cytology over total number of referrals; patient participation rate will be calculated by counting the number of eligible patients over number of patients consenting to participate in the study

Secondary Outcome Measures :
  1. Incidence of >/=HSIL (CIN 2/3) in the study population [ Time Frame: 18 months after last enrolled participant ]
    Determine the incidence of >/=HSIL (CIN 2/3) in the study population

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • One previous routine screening Pap test showing ASC-US, HPV positive
  • Two previous consecutive routine screening Pap tests showing ASC-US or LSIL

Exclusion Criteria:

  • previous hysterectomy
  • pregnant or considering pregnancy in the next 18 months
  • had a previous excisional or ablative procedure of the cervix
  • younger than 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03466710

Sponsors and Collaborators
University of Calgary
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Principal Investigator: Gregg Nelson, MD, FRCSC, PhD Tom Baker Cancer Centre, University of Calgary

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Responsible Party: University of Calgary Identifier: NCT03466710    
Other Study ID Numbers: HREBA.CC-16-0632_REN1
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Uterine cervical neoplasm
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female