Improving Cervical Cancer Screening Among HIV-Infected Women in India

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Brief Title

Improving Cervical Cancer Screening Among HIV-Infected Women in India

Official Title

Improving Cervical Cancer Prevention Among HIV-Infected Women Using Novel HPV Based Biomarker Assays

Brief Summary

      Background:

        -  Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical
           cancer are caused by the human papillomavirus (HPV). HPV is more common in women who
           have the human immunodeficiency virus (HIV). India has one of the highest rates of women
           who have both cervical cancer and HIV infection.

        -  Cervical cancer can be discovered in early stages by screening for HPV infection.
           Researchers want to compare new cervical cancer screening tests for HIV-infected women.
           They also want to know more about how HPV can lead to cervical cancer in HIV-infected
           women. To do so, they will hold a study to screen HIV-infected women in India.

      Objectives:

      - To improve cervical cancer screening methods in HIV-infected women in India.

      Eligibility:

        -  Women at least 18 years of age who have HIV infection.

        -  Participants will be recruited from HIV-focused health care clinics in Pune and Chennai,
           India.

      Design:

        -  Participants will have a physical exam and medical history. They will provide a urine
           sample and proof of HIV infection.

        -  Participants will have a gynecological exam. This will involve a pelvic exam and Pap
           smear to collect cells for study. It will also involve a cervical exam to look for
           precancerous cells. Cervical tissue may be collected.

        -  Participants will also provide a blood sample for testing.

        -  Participants will return in 2 weeks for the test results. If there are signs of
           precancerous or cancer cells, participants will be referred to a doctor for treatment.
    

Detailed Description

      Background:

      While HPV DNA testing is a highly sensitive screening method for cervical cancer, it cannot
      differentiate between the majority of benign infections and few persistent infections linked
      to cervical precancer. Given the high prevalence of carcinogenic HPV DNA and higher risk for
      cervical precancer and cancer among HIV-infected women, there is a substantial need for
      screening tests that are both adequately sensitive as well as specific, so as to maximize
      detection while reducing false-positive referrals. Furthermore, the unique immunological
      milieu in HIV-infected women presents significant opportunities to study natural history of
      HPV-mediated cervical oncogenic process in the context of immunosuppression.

      Objectives and Methods:

      The primary objective is to evaluate the clinical performance of two novel biomarker assays
      for detection of histologically-confirmed cervical intraepithelial neoplasia grade 2/3 or
      more severe (greater than or equal to CIN2 and greater than or equal to CIN3) among
      HIV-infected women. These tests include: (i) immunocytostaining by p16(INK4a)/Ki-67
      (biomarkers correlated with the oncogenic transformation of cervical cells following
      persistent carcinogenic HPV infection) and (ii) testing for HPV E6/E7 mRNA (expressed during
      progression of a transient to a transforming HPV infection). Secondary objectives include
      studying the association of risk factors and biomarkers with specific HPV genotypes and
      studying the interaction of HIV and HPV in cervical disease categories and in the context of
      immunosuppression.

      Eligibility:

      HIV-infected women, 18 years or older, with no history of previous treatment for cervical
      precancer/cancer, not currently pregnant, and able to provide informed consent.

      Design:

      This cross sectional study will be conducted in collaboration with Indian Council of Medical
      Research (ICMR), in three institutions, with substantial experience in conduct of clinical
      research on HIV/AIDS and HPV/cervical cancer: the National AIDS Research Institute (NARI) in
      Pune, the National Institute of Epidemiology (NIE) in Chennai, and the Jawaharlal Nehru
      Medical College (JNMC) in Belgaum. A total of 1000 HIV-infected women attending HIV care and
      treatment clinics in Pune (n=400) and Chennai (n=400), and Belgaum (n=200) will be recruited.
      According to routine practice, participants will undergo per-speculum examination and
      cervical specimen collection, followed by a detailed diagnostic colposcopy exam with biopsies
      as indicated for histological analysis. Cervical specimens will be used for liquid-based
      cytology as well as simultaneous independent assessment with p16(INK4a)/Ki-67 and HPV E6/E7
      mRNA testing. HPV DNA genotyping will be conducted by Linear Array HPV polymerase chain
      reaction. We will estimate the clinical performance (sensitivity, specificity, positive and
      negative predictive values, Youden s Index, and positive and negative likelihood ratios with
      95% confidence intervals) of individual tests and combinations for prevalent detection of
      histologically-confirmed greater than or equal to CIN2 and greater than or equal to CIN3
      among HIV-infected women. Additionally we will estimate age-specific and disease-specific HPV
      prevalence rates and HPV genotype composition, examine factors associated with greater than
      or equal to CIN2/greater than or equal to CIN3 lesions, examine the relationships of
      biomarker positivity at the HPV genotype-specific level, and evaluate the role of
      immunosuppression on HPV-mediated carcinogenesis. This study will permit validation of
      collection, transport, storage, and implementation protocols, allow evaluation of the field
      adoption and efficacy of these newer assays, describe the sensitivity and specificity of any
      of the tests or combinations with reasonable precision for a wide range of prevalence of
      greater than or equal to CIN3, and provide a resource for studies of HIV-HPV coinfection.
    


Study Type

Observational


Primary Outcome

Cervical Intraepithelial Neoplasia Grade II or more severe


Condition

Cervical Cancer


Study Arms / Comparison Groups

 Cohort
Description:  HIV-infected women attending HIV care and treatment clinics in Pune, Chennai, andBelgaum in India.

Publications

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

Recruitment Information



Estimated Enrollment

1000

Start Date

November 28, 2012

Completion Date

October 8, 2020

Primary Completion Date

October 8, 2020

Eligibility Criteria

        -  INCLUSION CRITERIA:

               1. Female greater than or equal to 18 years of age at study entry. This ensures that
                  all participants are at or above legal age in India for giving informed consent.

               2. Confirmed HIV-1 infection.

               3. For women of reproductive potential, a negative urine pregnancy test with a
                  sensitivity of <25mlU/mL prior to study entry. This ensures that only
                  non-pregnant women are included. While pregnancy is not an absolute
                  contraindication for screening, certain invasive clinical procedures are often
                  postponed until after pregnancy.

               4. If recently given birth, must be at least 12 weeks postpartum.

               5. Physical and mental ability and willingness of participant to provide written
                  informed consent.

        EXCLUSION CRITERIA:

          1. Current or prior history of cervical, vaginal, or vulvar cancer.

          2. Prior treatment for cervical disease; including treatment by cervical cryotherapy,
             LEEP, cervical conization, total or partial hysterectomy, chemotherapy, or radiation
             therapy.

          3. Prior cervical procedure in the past 6 months, including dilatation and curettage
             (D&C).

          4. Serious illness requiring systemic treatment or hospitalization within 21 days prior
             to study entry.

          5. Active drug or alcohol use or dependence or any other condition that, in the opinion
             of the site investigator, would interfere with the participant s ability to adhere to
             study requirements.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nicolas Wentzensen, M.D., , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT02247999

Organization ID

999913037

Secondary IDs

13-C-N037

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Nicolas Wentzensen, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

October 2020