Anal Injury Screening for High Risk HPV

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Brief Title

Anal Injury Screening for High Risk HPV

Official Title

Anal Injury Screening for High Risk HPV in Population With Susceptibility to Anal Cancer Development

Brief Summary

      The diagnosis of anal cancer is superior with the Anal Test system compared to liquid
      cytology and anoscopy.
    

Detailed Description

      DESIGN METHODOLOGY: Prospective, cross-sectional, comparative, double-blind, randomized.

      STUDY POPULATION:

      Group 1, 250 HIV negative patients (150 men and 100 women) from the oncology service who
      agree to participate in the study and with a negative diagnosis for HIV made at the
      Infectious Diseases Service.

      Group 2, 250 HIV positive patients (150 men and 100 women) attended by the Infectious Disease
      Service diagnosed with HIV positive. The sample size was adjusted to the donation of 500 Anal
      Test devices and the subsequent molecular determinations for each sample.

      PROCEDURE:

      In this study, men and women between 30 and 65 years old with active sexual life and who are
      susceptible to the development of anal cancer can participate.

        1. Immunosuppressed patients, a) infected with the human immunodeficiency virus, HIV or b)
           by medication after receiving an organ transplant.

        2. Individuals who have or have had anal intercourse. Women with a history of cervical,
           vulva, or vaginal cancer.

      PLANNED ACTIVITIES:

      First: Candidate patients who meet the inclusion criteria will have an explanation of the
      importance of their participation in this protocol, all their doubts will be resolved and
      they will be asked to sign the letter of informed consent with witnesses.

      Second: After signing the letter of consent, the service provider will make a questionnaire
      to know the clinical characteristics and identification of the patient, they will be assigned
      a consecutive number.

      If assignation is a non-number, the self-test will be performed as the first in sequence,
      followed by liquid cytology and then anoscopy.

      If assignation is an even number, the liquid cytology will be done as the first in sequence,
      followed by self-test and the anoscopy.

        -  For the Self-Test: the patient will be given the Anal Test medical device with the
           following recommendations: a) washing of patient hands, b) removing the plastic
           packaging from the device, c) removing the cover, d) Holding it by the handle, the
           device will be inserted into the anus, e) patient will be left intro-anal for 30 seconds
           and then it will be rotated 180 degrees, f) it will slowly withdraw the device and g) it
           will be delivered to the assistant nurse.

        -  The nurse will put the device (with the sample) in a tube with 5 ml of PreservCyt
           solution and close it tightly.

        -  The tube with the device and the sample will be kept at room temperature until transport
           to the laboratory for processing and obtaining results.

        -  The patient will answer a satisfaction questionnaire.

        -  An appointment will be given three weeks later to grant the result.

      Third:

      Processing of samples and issuance of results will be done in an external laboratory outside
      the Hospital General de México. In the Molecular Biology Laboratory, the coded samples will
      be processed as follows:

        1. DNA will be extracted using the Abbott Real-Time Polymerase Chain Reaction (RT-PCR)
           technology procedures, with the m2000 system. Presence and identification will be
           determined for HPV-Ar 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

        2. Only the positive samples from the first step; mRNA will be extracted and the viral
           oncology proteins expression of the E6 and E7 will be quantified for the following
           specific HPV-Ar 16, 18, 31, 33, 45, 52 and 58 by Real-Time Polymerase Chain Reaction
           (RT-PCR). The results of the laboratory studies will be sent to the responsible
           investigator.

        3. Processing of samples in an external laboratory outside the Hospital General de México
           and issuance of results. In the Molecular Biology Laboratory, the coded samples will be
           processed as follows:

             1. DNA will be extracted using the Abbott Real-Time Polymerase Chain Reaction (RT-PCR)
                technology procedures, with the m2000 system. The presence and identification will
                be determined for HPV-Ar 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

             2. Only the positive samples from the first step; mRNA will be extracted and the
                expression of the viral oncology proteins E6 and E7 will be quantified for the
                following specific HPV-Ar 16, 18, 31, 33, 45, 52 and 58 by Real-Time Polymerase
                Chain Reaction (RT-PCR). The results of the laboratory studies will be sent to the
                responsible investigator.

      Fourth:

      If they are positive to HPV-Ar, investigator will follow-up patient to corroborate the
      elimination or persistence of the HPV infection (surveillance). Patients who are positive for
      E6 and E7 messenger ribonucleic acid (mRNA) will be cited for high-resolution anoscopy and
      biopsy, negative patients will be under surveillance. Patients who are normal or with Low
      grade Intraepithelial Lesion (lSIL) (NIA1) by cytology will be under surveillance. High grade
      Intraepithelial Lesion (HSIL) patients (NIA2 and NIA3) will be scheduled for high-resolution
      anoscopy and biopsy.

      STATISTICAL ANALYSIS Statistical results will be reported first in a descriptive way,
      reporting means and standard deviations of the main study variables, as well as percentages
      of the presence of high-risk human papillomavirus analyzed in this investigation. Bi-variate
      comparative tests such as t-Student or Chi-square tests will be applied to identify possible
      differences between the group of people with the presence/absence of high-risk viruses and
      demographics and clinical variables such as the presence of HIV. When there is no normality,
      the non-parametric Mann-Whitney U test will be applied. Linear correlations will be analyzed
      with the Spearman and Pearson correlation tests depending on the type of analyzed variables.
      Data concordance analysis such as the kappa test will be performed because due to presence of
      human papillovirus HPV-Ar sub-types as well as lesion type compared to the results of liquid
      anal cytology that in this study the investigators will consider our "gold standard", in
      addition to perform sensitivity, specificity, positive and negative predictive value tests.
      Finally, and although it is not part of our main objectives, the investigators will analyze
      the possible associate risk factors with the presence of high-risk human papillovirus (HPV)
      using logistic regression models.

      ETHICAL ASPECTS AND BIOSECURITY. ETHICS. What is indicated in relation to ethics on human
      studies will be strictly followed according to Regulations of the General Law of Health in
      Matters of Health Research of Mexico, and the Declaration of Helsinki, considering subsequent
      versions.

      INFORMED CONSENT LETTER. SAFETY The subject under study will have complete information on the
      procedures that will be carrying out. The studies will be done exclusively with the
      assistance of the authorized research team and in consulting rooms belonging to the Oncology
      Service. If the subject under study expresses his desire not to participate in the process,
      it will be suspended immediately.

      All the studies to be carried out on the patient are totally safe and innocuous.
    


Study Type

Interventional


Primary Outcome

Percentage of positive results for Anal Test system versus anal liquid cytology and anoscopy for the presence of high-risk human papillomaviruses

Secondary Outcome

 Number of predictive value for positive and negative results for self-test versus liquid cytology results

Condition

Anal Injury

Intervention

Self test sample

Study Arms / Comparison Groups

 Group 1, HIV negative patients.
Description:  Only HIV negative patients

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

Diagnostic Test

Estimated Enrollment

500

Start Date

August 30, 2020

Completion Date

January 31, 2021

Primary Completion Date

September 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women between 30 and 65 years old.

          -  They agree to participate in the study and sign informed consent.

          -  They have not received previous treatments for HPV or had previous intraepithelial
             lesions or anal cancer.

          -  Immunosuppressed patients.

          -  Women with LIAG of the genital tract (cervix, vagina, or vulva).

          -  Patients who have had anal intercourse

        Exclusion Criteria:

          -  Patients sexually inactive

          -  Subjects who had anal sex in less than 24 hours prior to the study.

          -  Patients with local medication application (enemas, suppositories).
      

Gender

All

Ages

30 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Luis G Molina Fernández de Lara, 5550043807, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT04512508

Organization ID

DI/20/111/03/11


Responsible Party

Principal Investigator

Study Sponsor

Hospital General de México Dr. Eduardo Liceaga


Study Sponsor

Luis G Molina Fernández de Lara, Study Chair, Hospital General de México Eduardo Liceaga


Verification Date

August 2020