Post Colposcopy Management of ASC-US and LSIL Pap Tests
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|ClinicalTrials.gov Identifier: NCT03466710|
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Screening||Procedure: Colposcopy Other: Pap test Diagnostic Test: HPV test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Colposcopy arm
Patients received colposcopy as per standard of care
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.
- 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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03466710
|Principal Investigator:||Gregg Nelson, MD, FRCSC, PhD||Tom Baker Cancer Centre, University of Calgary|