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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01881659
Other study ID # IEC 12-27
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2013
Est. completion date December 31, 2023

Study information

Verified date March 2023
Source International Agency for Research on Cancer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
HPV screening
Women who signed informed consent will be screened with HPV testing.

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Sponsors (1)

Lead Sponsor Collaborator
International Agency for Research on Cancer

Countries where clinical trial is conducted

Argentina,  Bolivia,  Colombia,  Costa Rica,  Honduras,  Mexico,  Paraguay,  Peru,  Uruguay, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.
Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
Detected after initial HPV screening or at second screening round 18 months since entry
Secondary Number of participants with histologically confirmed CIN2, CIN3 or cancer (CIN2+) on reviewed histology There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.
Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
Detected after initial HPV screening or at second screening round 18 months since entry
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