HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings

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Brief Title

HRME: Screening for Cervical Cancer and Its Precursors in Low-Resource Settings

Official Title

Point-of-Care, Real-Time Optical Imaging to Enable Screening for Cervical Cancer and Its Precursors in Low-Resource Settings

Brief Summary

      A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to
      follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME.
      The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure
      necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of
      a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and
      treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to
      women who have screened positive during a prior visit with the mobile screening unit. The
      mobile diagnostic and treatment unit will be constructed and maintained at BCH.
    

Detailed Description

      A new mobile diagnostic and treatment unit is being developed by BCH to address the loss-to
      follow-up associated with the mobile screening program and demonstrate POC diagnosis by HRME.
      The mobile diagnostic and treatment unit will be equipped with the tools and infrastructure
      necessary to perform HRME, VIA, colposcopy, biopsy and treatment with cryotherapy. A team of
      a colposcopist, nurse, nursing assistant, and driver will staff the mobile diagnostic and
      treatment unit. The unit will travel to offer follow-up diagnostic and treatment services to
      women who have screened positive during a prior visit with the mobile screening unit. The
      mobile diagnostic and treatment unit will be constructed and maintained at BCH.

      The study will include 200 women with abnormal Pap tests identified through BCH's existing
      mobile screening program. Participants will be randomized by cluster to receive follow up
      care either through the new mobile diagnostic and treatment unit (experimental arm) or
      through recall to BCH (standard of care). We are using cluster randomization to avoid
      contamination between arms because some women getting mobile unit services may be concerned
      that they are getting lesser services than what they could get at BCH or some women being
      referred to BCH may resent not having the convenience of a mobile unit. Because the areas
      visited by the mobile units are geographically isolated, we do not anticipate any patients
      crossing over to the other study arm.

      VIA will be performed with 5% acetic acid applied to the cervix and any abnormal lesions
      noted. Standard colposcopy will then be performed and abnormal lesions noted. Proflavine
      (0.01%) will then be applied topically. Lugol's solution will then be applied and colposcopy
      performed and abnormal lesions noted. Proflavine (0.01% will then be reapplied. HRME images
      will be acquired from any areas that are abnormal by VIA and/or colposcopy. In addition, all
      4 quadrants will be probed by HRME (4Q HRME) to ensure that non-acetowhite lesions are also
      located. The provider will note their impression of the lesion and the HRME image at each
      site (normal, benign, low-grade precancer, high grade precancer or cancer). The entire HRME
      imaging procedure should add less than 10 minutes to the standard colposcopy exam. VIA,
      colposcopy and HRME observations will recorded by quadrant. Any abnormal areas by VIA and/or
      colposcopy will be biopsied. If no abnormal areas are noted, one cervical biopsy will be
      obtained from a normal appearing area with a HRME image of this area obtained. Two expert
      pathologists, blinded to all study results, will review histology and classify as either
      normal, CIN1, CIN2, CIN3, AIS or cancer, according to standard criteria; discrepant results
      will be resolved by consensus review.

      TREATMENT:

      Women randomized to the mobile diagnostic and treatment unit who have a HSIL Pap and/or a
      lesion noted by VIA and/or colposcopy will undergo immediate treatment with cryotherapy
      following biopsies, provided the lesion meets the following criteria: 1) covers <75% of the
      ectocervix; 2) can be fully covered with the cryotherapy tip; 3) does not extend into the
      endocervical canal. If the colposcopic findings are concerning for invasive cancer or the
      lesion is not amenable to treatment with cryotherapy, the patient will be referred
      immediately to BCH for additional evaluation and treatment per standard of care.

      Women with a biopsy showing CIN2+ who did not undergo cryotherapy due to a negative
      VIA/colposcopy, will be recalled to BCH immediately for LEEP (CIN2/3). Women with a biopsy
      showing CIN2/3 who underwent cryotherapy will be recalled to BCH or the mobile unit for a
      6-month follow-up visit. If persistent or recurrent disease is noted, they will be referred
      to BCH for further treatment. Women with a biopsy showing cancer of adenocarcinoma in situ
      (AIS) will be recalled to BCH immediately for cold knife cone (CKC) or other evaluation and
      treatment per standard of care regardless of whether or not cryotherapy was performed. Women
      with CIN1 or less will return for follow-up to the mobile unit or BCH for follow-up at 12
      months. Women randomized to return to a central facility for follow up care will undergo VIA,
      colposcopy, HRME and biopsies as described above. Patients found to have CIN2+ will be
      treated per standard of care at BCH.
    


Study Type

Interventional


Primary Outcome

Treatment completion rate.

Secondary Outcome

 Efficacy (ability to detect CIN 2+ in women with previous abnormal Pap test).

Condition

Neoplasia of the Uterine Cervix

Intervention

High-Resolution Microendoscopy Imaging

Study Arms / Comparison Groups

 HRME - Prevention Mobile Unit
Description:  Procedures to be done in the mobile unit (van): Visual inspection will be performed with 5% acetic acid (VIA) applied to the cervix followed by standard colposcopy. Proflavine (0.01%) will then be applied topically. Lugol's solution will then be applied and colposcopy performed and abnormal lesions noted. HRME images will be acquired from any areas that are abnormal by VIA and/or colposcopy. VIA, colposcopy and HRME observations will recorded by quadrant. Any abnormal areas by VIA and/or colposcopy will be biopsied. If no abnormal areas are noted, one cervical biopsy will be obtained from a normal appearing area with a HRME image of this area obtained.

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

Device

Estimated Enrollment

200

Start Date

September 1, 2015

Completion Date

December 31, 2016

Primary Completion Date

August 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Women with an abnormal Pap test (atypical squamous cells of undetermined significance
             or more severe interpretations [≥ASC-US])

          2. Women with an intact cervix (patients who have undergone previous LEEP, cone and/or
             cryotherapy are eligible)

          3. Women of childbearing potential must have a negative urine or serum pregnancy test

          4. Women who are at least 18 years of age or older

          5. Ability to understand and the willingness to provide informed consent and sign a
             written Informed Consent Document (ICD)

        Exclusion Criteria:

          1. Women <18 years of age

          2. Women who have undergone a hysterectomy with removal of the cervix

          3. Women with a known allergy to proflavine or acriflavine

          4. Women who are pregnant or nursing

          5. Women unable or unwilling to provide informed consent or sign a written Informed
             Consent Document (ICD)
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02494310

Organization ID

HRME-UH2


Responsible Party

Principal Investigator

Study Sponsor

Barretos Cancer Hospital

Collaborators

 William Marsh Rice University

Study Sponsor

, , 


Verification Date

February 2017