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Comparative pilot study about HPV test with partial genotyping in primary screening versus other strategies for cervical cancer population screening, CRYGEN 16/18 study
Estudio piloto comparativo del test VPH con genotipado parcial en primera línea frente a otras estrategias de cribado poblacional del cáncer de cérvix. Estudio CRYGEN 16/18
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Juan J. Hernández-Aguadoa, Jesús de La Fuente-Valeroa, Mar Ramírez Menab, Luis Ortega-Medinac, José Antonio Vidart Aragónb, Juan Carlos Galánd,e,
Corresponding author
a Servicio de Ginecología, Hospital Universitario Infanta Leonor, Madrid, Spain
b Servicio de Ginecología, Hospital Universitario Clínico San Carlos, Madrid, Spain
c Servicio de Anatomía Patológica, Hospital Universitario Clínico San Carlos, Madrid, Spain
d Servicio de Microbiología, Hospital Universitario Ramón y Cajal. IRYCIS, Madrid, Spain
e CIBER Epidemiología Salud Pública (CIBERESP), Madrid, Spain
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Received 07 April 2021. Accepted 12 July 2021
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Tables (4)
Table 1. Molecular detection of high-risk HPV genotypes detected (n=1988).
Table 2. Cytological evaluation of the samples included in the study (n=1973).
Table 3. Correlation of the molecular detection of HPV with partial genotyping, with the results observed by abnormal cytology, differentiating between the different grades of lesions and the results of the biopsies of patients referred to colposcopy.
Table 4. Comparative analysis of the different population screening strategies used for cervical cancer.
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Abstract
Introduction

The early detection of cervical cancer requires the implementation of molecular screening programmes for human papillomavirus (HPV). However, there are discrepancies in the optimization of screening protocols. The performance of 10 primary screening strategies based on molecular, cytological or combined techniques is now evaluated.

Material and Methods

A blind, prospective, and interventional study was designed in 1.977 35-year-old women. The molecular determination was carried out by the Cobas 4800 HPV platform. Cytological analysis were performed on the same samples without knowledge of the result of the molecular assay. All women in whom HPV-16/HPV-18 was detected or presented cytological alteration together with detection of other high-risk genotypes (HPVhr) were referred to colposcopy.

Results

The molecular assay detected the presence of HPVhr genotypes in 12.5% of the women, while only 8.1% of the cytologies were pathological. Among the patients referred to colposcopy, in 19.5% high-grade lesions were observed, being HPV-16 present in 65.3% of them. In six of these high-grade lesions (associated with HPV-16 in all cases), cytology was reported as normal. The follow-up one year later, of women with normal cytology and HPVhr detection a HSIL/CIN2+ lesion was detected (associated to HPV-33). In the comparative study with other strategies, the protocol called CRYGEN 16/18 yielded the best balance of sensitivity and specificity with the least referral to colposcopy.

Conclusions

Performing molecular detection of HPVhr with partial first-line genotyping of at least HPV-16, with direct referral to colposcopy, increases the detection rate of HSIL/CIN2+ lesions.

Keywords:
HPV screening
HPV-16
Cervical cáncer
Partial genotyping
Resumen
Introducción

La detección precoz del cáncer de cérvix requiere la implementación de programas de cribado del virus del papiloma humano (VPH). Sin embargo, existen discrepancias en la optimización de esas estrategias. Se evalúa el rendimiento de 10 protocolos basados en técnicas moleculares, citológicas o combinadas en cribado primario.

Material y Métodos

Se diseña un estudio ciego, prospectivo e intervencionista en 1.977 mujeres de 35 años. La determinación molecular se realizó por la plataforma Cobas 4800 HPV. Los análisis citológicos se realizaron en las mismas muestras sin conocimiento del resultado molecular. Todas las mujeres en las que se detectaba VPH-16/VPH-18 o presentaban alteración citológica y detección de otros genotipos de alto riesgo (VPHar) eran derivadas a colposcopia.

Resultados

El ensayo molecular detectó presencia de VPHar en 12,5% de las mujeres, mientras solo 8,1% de las citologías fueron patológicas. En 19,5% de las pacientes derivadas a colposcopia revelaron lesiones de alto grado, estando VPH-16 presente en el 65,3% de ellas. En seis de esas ocasiones (VPH-16 siempre presente), la citología había sido informada como normal. El seguimiento al año de las mujeres con citología normal y detección de VPHar, detectó una lesión HSIL/CIN2+ (asociada a VPH-33). En el estudio comparativo con otras estrategias, el protocolo denominado CRYGEN 16/18 rindió el mejor equilibrio de sensibilidad y especificidad con la menor derivación a colposcopia.

Conclusiones

La realización de detección molecular de VPH con genotipado parcial en primera línea, al menos VPH-16, con derivación directa a colposcopia, aumenta la tasa de detección de lesiones HSIL/CIN2+.

Palabras clave:
Cribado del virus del papiloma humano
VPH-16
Cáncer cuello útero
Genotipado parcial

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