Costa Rican Natural History Study of HPV and Cervical Neoplasia

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Brief Title

Costa Rican Natural History Study of HPV and Cervical Neoplasia

Official Title

Costa Rican Natural History Study of HPV and Cervical Neoplasia

Brief Summary

      A population-based study was initiated in Costa Rica in June 1993 to investigate the natural
      history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months,
      ending in December 1994, 10,080 women were recruited into our study, after informed consent
      was obtained. At the initial recruitment visit, all women were administered a brief risk
      factor questionnaire, had 15ml of blood collected and, if sexually active, were given a
      pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were
      additional cervical cells which were then used for additional monolayer smears (ThinPrep) and
      for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were
      also taken as a third screening test. Based on these screening tests, women were referred to
      colposcopy, at which time a more detailed risk factor questionnaire was administered,
      additional cervical cells and blood (15ml) were collected, and histological specimens were
      obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion
      (HSIL) or cervical cancer were treated by Social Security Administration clinicians using
      standard local protocols.

      Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who
      have been followed as part of our longitudinal study. Three distinct groups of women of
      approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The
      first group consists of women who at enrollment had evidence of low-grade cervical lesions
      (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being
      followed actively at 6-12 month intervals through their seventh anniversary in the cohort.
      The second group consists of women who were cytologically normal at enrollment but randomly
      selected for active follow-up. This second group will be seen once after enrollment, at their
      fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth
      anniversary visit will be added to the first group described above and followed at 6-month
      intervals. The final group consists of the remaining women in our cohort (all cytologically
      normal at enrollment). These women are being followed passively via linkage to the cytology
      and tumor registries in Cost Rica.

      Clinical visits conducted during follow-up consist of a brief personal interview that
      collects information on exposures since enrollment, the collection of 15ml blood, and a
      pelvic examination. Pap smear is prepared during the pelvic examination, and additional
      cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for
      human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also
      collected from each participant at the time of their follow-up visits.

      During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear,
      ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from
      the study, and treated by Social Security Administration clinicians using standard local
      protocols.
    

Detailed Description

      A population-based study was initiated in Costa Rica in June 1993 to investigate the natural
      history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months,
      ending in December 1994, 10,080 women were recruited into our study, after informed consent
      was obtained. At the initial recruitment visit, all women were administered a brief risk
      factor questionnaire, had 15ml of blood collected and, if sexually active, were given a
      pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were
      additional cervical cells which were then used for additional monolayer smears (ThinPrep) and
      for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were
      also taken as a third screening test. Based on these screening tests, women were referred to
      colposcopy, at which time a more detailed risk factor questionnaire was administered,
      additional cervical cells and blood (15ml) were collected, and histological specimens were
      obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion
      (HSIL) or cervical cancers were treated by Social Security Administration clinicians using
      standard local protocols.

      Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who
      were followed as part of our longitudinal study. Three distinct groups of women of
      approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The
      first group consists of women who at enrollment had evidence of low-grade cervical lesions
      (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group was
      followed actively at 6-12 month intervals through their seventh anniversary in the cohort.
      The second group consists of women who were cytologically normal at enrollment but randomly
      selected for active follow-up. This second group was seen once after enrollment, close to
      fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth
      anniversary visit were added to the first group described above and followed at 6-month
      intervals. The final group consists of the remaining women in our cohort (all cytologically
      normal at enrollment). These women were followed passively via linkage to the cytology and
      tumor registries in Costa Rica.

      Clinical visits conducted during follow-up consisted of a brief personal interview that
      collects information on exposures since enrollment, the collection of 15ml blood, and a
      pelvic examination. A Pap smear was prepared during the pelvic examination, and additional
      cervical specimens were collected and used to prepare a monolayer smear (ThinPrep) and for
      human papillomavirus and other testing. Similar to the enrollment visit, cervigrams were also
      collected from each participant at the time of their follow-up visits.

      During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear,
      ThinPrep, cervicography, or by visual inspection) were referred to colposcopy, censored from
      the study, and treated by Social Security Administration clinicians using standard local
      protocols.
    


Study Type

Observational


Primary Outcome

Natural History of human papillomaviruses (HPV) and cervical neoplasia


Condition

Cervical Neoplasia


Study Arms / Comparison Groups

 Women in Costa Rica
Description:  Examining the natural history of HPV and cervical neoplasia in Costa Rican women.

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

11545

Start Date

May 20, 1999

Completion Date

March 12, 2012

Primary Completion Date

March 12, 2012

Eligibility Criteria

        -  INCLUSION CRITERIA FOR FOLLOW-UP PHASE OF NATURAL HISTORY STUDY:

        Less than 35 years of age.

        Intact uterus (non-hysterectomized).

        In good general health.

        Non-pregnant.

        For women not using OCs: Having regular cycles [cycles 25-35 days in length].

        HPV16 seropositive [based on data from latest visit tested].

        No evidence of HSIL/cancer [based on data from latest visit within cohort].

        Willing to participate [informed consent].

        INCLUSION CRITERIA FOR FOLLOW-UP PHASE OF COHORT STUDY:

        Must be between the ages of 45 to 70 years.

        Women who do not have a final diagnosis of HSIL.
      

Gender

Female

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Mark H Schiffman, M.D., , 

Location Countries

Costa Rica

Location Countries

Costa Rica

Administrative Informations


NCT ID

NCT00342173

Organization ID

999999030

Secondary IDs

OH99-C-N030

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Mark H Schiffman, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

March 2020