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Low-Cost Molecular Cervical Cancer Screening Study

NCT01231945 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7500

Last updated 2017-07-02

No results posted yet for this study

Summary

Background:

\- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses.

Objectives:

* To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions.
* To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment.
* To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions.

Eligibility:

\- Women between 25 and 65 years of age who live in rural China.

Design:

* This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup.
* Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration.
* Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study.
* A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities.
* At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..

Conditions

  • DNA Probes
  • E6 Protein
  • Uterine Cervical Neoplasms
  • HPV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-11
Completion
2010-12-20

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01231945 on ClinicalTrials.gov