Status:

TERMINATED

Costa Rican Natural History Study of HPV and Cervical Neoplasia

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Cervical Neoplasia

Eligibility:

FEMALE

18-100 years

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 Decem...

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 Decem...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 20 1999

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 12 2012

    Estimated Enrollment :

    11545 Patients enrolled

    Trial Details

    Trial ID

    NCT00342173

    Start Date

    May 20 1999

    End Date

    March 12 2012

    Last Update

    March 16 2020

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Costa Rican Social Security Administration

    Tres Ríos, Costa Rica