Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

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Brief Title

Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

Official Title

Randomized Controlled Trial Comparing Routine Colposcopy to HPV Testing to Identify Persistent or Recurrent High Grade Cervical Cancer Precursors

Brief Summary

      This trial will compare HPV testing to the routine colposcopy in the follow-up of women
      treated for cervical high grade lesions. Women will be assigned randomly (by chance) after
      treatment of cervical pre-cancer to be either (1) followed-up by colposcopy, or (2) undergo
      HPV testing. Women found to have disease by either strategy will be offered re-treatment. For
      the next 2 years participants will undergo yearly, in depth, evaluation to assess the cervix
      for precancer. We will then be able to compare which of the 2 follow-up strategies worked
      best.
    

Detailed Description

      Background and rational: Cervical cancer ranks twelfth in terms of cancer mortality in
      Canadian women, but remains the second most frequent cancer in Canadian women aged 20-44.
      Fortunately, its natural history makes it an ideal candidate for successful prevention.
      Cervical cancer and its precursors are caused by a persistent infection of the cervical
      epithelium by one of the 15 oncogenic (or high risk) types of human papillomaviruses (HPVs).
      The preinvasive changes of cervical intra-epithelial neoplasia (CIN) can be identified
      through cervical cytology (also known as the Pap test). When cellular abnormalities are
      identified, women are referred for diagnostic testing. High-grade precursor lesions (CIN2/3)
      carry a high risk of progression to invasive cancer and for this reason their treatment is
      recommended. Treatment success rates of CIN2/3 are 85%. However, those who fail treatment
      need to be identified promptly because their risk of invasive disease is increased more then
      10 fold. The current strategy used in Canada to identify treatment failures consists of a
      follow-up every 6 months in colposcopy clinics for 2 years. Recent research underlines the
      fact that routine colposcopy is unreliable and may miss significant lesions. The
      identification of oncogenic HPV DNA in the cervical secretions is known as HPV testing. A few
      studies have investigated the use of HPV testing in the identification of treatment failures.
      Although they point to a very good sensitivity (90-95%) there were methodological
      limitations: studies were small; the HPV test used was often not suitable for clinical
      laboratory use; endpoints were not assessed by histological confirmation. Most importantly,
      none compared HPV testing to colposcopy, the strategy used in Canada. Research question: Is
      HPV testing more sensitive than routine colposcopy to identify CIN2/3 treatment failures?
      Methodology: Design: We propose a parallel randomized controlled trial, where participants
      will be randomized 1:1 to routine colposcopy vs. HPV testing after treatment of CIN2/3
      lesions. Study Population: Women treated for high-grade precursor lesions. Exclusion criteria
      are: pregnancy, less than 18 years of age, known immunosuppression or immunodeficiency,
      unable to provide informed consent. Study interventions: (1) HPV testing with Hybrid Capture
      2. (2) Routine colposcopy. In order to evaluate the performance of the current follow-up
      strategy, there will be no standardized protocol for the colposcopy intervention, but
      documentation of procedures will be done. Patients will receive the study interventions 6
      months after treatment. All participants will undergo expert diagnostic assessment at 12 and
      24. Sample size calculation and recruitment rate. The sample size was calculated to have 80%
      power to detect an increase in sensitivity of 15%, with an alpha set at 0.05 (double sided
      test). Assuming a conservative baseline sensitivity of 70% for colposcopy, 134 cases of
      recurrent/persistent disease will be necessary in each study group. Assuming a 15% failure
      rate of treatment and a 20% drop out rate, a total of 2250 participants will need to be
      accrued. Recruitment will take place in high volume colposcopy clinics across Canada over 2
      years. Analysis: The primary analysis will consist of the comparison of the diagnostic
      indices of the 2 follow-up strategies: sensitivity, specificity, positive and negative
      predictive values (with their 95% asymptotic confidence intervals). Cumulative
      persistent/recurrent cases identified during the 2 year follow-up will make up the case
      group. Since all participants will undergo expert diagnostic assessment. No subgroup analysis
      will be performed. 4. Expected contribution: The result from this trial will provide high
      quality data on which to base management recommendation. If HPV testing is found to be more
      sensitive than routine colposcopy, follow-up of treated lesion may occur mainly in primary
      care physician's office with HPV testing, reducing costs, and making it possible to focus
      colposcopy activities on a group of women truly at risk of significant disease.
    


Study Type

Interventional


Primary Outcome

Sensitivity of HPV testing and sensitivity of routine colposcopy to identify CIN2 or worse disease after treatment for CIN 2/3

Secondary Outcome

 The area under the respective ROC curves (HPV testing and routine colposcopy)

Condition

High Grade Cervical Intra-epithelial Neoplasia

Intervention

high risk HPV DNA testing

Study Arms / Comparison Groups

 HPV testing
Description:  Women randomized to this arm will undergo high risk HPV DNA testing using Hybrid Capture 2®.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

2253

Start Date

January 2010

Completion Date

June 2021

Primary Completion Date

September 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Woman ≥ 18 years old 19 in British Columbia, Nova Scotia and Newfoundland)

          -  Understands English or French (for sites where French speaking coordinator is
             available)

          -  Is treated for biopsy proven CIN II, III or AIS

          -  Understands study procedures, available alternatives treatment, risks related to
             study, and accepts voluntarily to participate by signing the ICF.

        Exclusion Criteria:

          -  has been treated for cervical cancer or pre-cancer in the past

          -  Participant has known immunosuppression or immunodeficiency

          -  Planned hysterectomy

          -  Participant is receiving or has received one of the following treatment :

               -  Immunosuppressive therapy in the three months prior to enrollment

               -  Corticosteroid therapy in the two weeks prior to enrollment

               -  Two or more courses of corticosteroids (orally or parenterally) lasting at least
                  one week in duration in the year prior to enrollment (inhalation, nasal or
                  topical corticosteroids are permitted)

          -  There is a strong probability that the participant will not follow the procedures of
             study, will not come to its appointment, or plans a delocalization throughout study.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marie-Hélène Mayrand, MD,PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01051895

Organization ID

020428


Responsible Party

Sponsor

Study Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

 Terry Fox Foundation

Study Sponsor

Marie-Hélène Mayrand, MD,PhD, Principal Investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal


Verification Date

June 2020