Intraoperative HPV Testing Evaluation

NCT04190472 | Unknown

• 1 other identifier: IOP VPH IOP Protocol
• Study Type: observational
• Target: 1,553
• Locations: 0 countries
• Sites: N/A

Brief Summary

High-grade intraepithelial lesion/cervical intraepithelial neoplasia grade 2-3 is a premalignant cervical lesion caused by persistent high-risk human papillomavirus infection. Human papillomavirus test is a very sensitive risk marker of cervical cancer and it has been incorporated in the follow-up after high-grade intraepithelial lesion treatment. Papillomavirus test performed intraoperatively could be a beneficial approach to anticipate treatment failure, allow for early management and consequently a reduction in costs. The aim of this study is to evaluate if the IOP-HPV test has non-inferior diagnostic utility of HSIL/CIN2-3 recurrence at 24 months as the HPV test performed 6 months after treatment.

Conditions

HSIL, High Grade Squamous Intraepithelial Lesions; Recurrence

Keywords

HSIL; Follow-up; LEEP

Outcome Measures

Primary Outcomes (1)

• Intraoperatory HPV testing evaluation: non- inferior study of diagnostic utility of HSIL/CIN2-3 recurrence as 6-months HPV test.

  Evaluate if the IOP-HPV test has non-inferior diagnostic utility of HSIL/CIN2-3 recurrence at 24 months as the HPV test performed 6 months after LEEP.

  24 months of follow-up after LEEP

Study Arms (1)

IOP VPH test

Immediately after the LEEP, a cervical sample is token for the IOP-HPV test

Diagnostic Test: IOP HPV test

Interventions

IOP HPV test DIAGNOSTIC_TEST

Immediately after the LEEP, a cervical sample was taken for the IOP-HPV test

IOP VPH test

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed of HSIL/CIN2-3 by colposcopy guided biopsy (CGB) or endocervical curettage (ECC) in the 3 months prior to LEEP and/or confirmation of HSIL/CIN2-3 in the pathologic study of the surgical specimen

You may qualify if:

• Diagnosis of HSIL/CIN2-3 by colposcopy guided biopsy (CGB) or endocervical curettage (ECC) in the 3 months prior to LEEP and/or confirmation of HSIL/CIN2-3 in the pathologic study of the surgical specimen

You may not qualify if:

• Patients with acquired or congenital immunosuppression
• Patients undergoing chronic immunosuppressive treatments, prior treatment with LEEP
• Patients in whom HSIL/CIN2-3 was not histologically confirmed.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Related Publications (13)

• Pinto AP, Crum CP. Natural history of cervical neoplasia: defining progression and its consequence. Clin Obstet Gynecol. 2000 Jun;43(2):352-62. doi: 10.1097/00003081-200006000-00015. No abstract available.

  PMID: 10863633 BACKGROUND

• Castellsague X, Remy V, Puig-Tintore LM, de la Cuesta RS, Gonzalez-Rojas N, Cohet C. Epidemiology and costs of screening and management of precancerous lesions of the cervix in Spain. J Low Genit Tract Dis. 2009 Jan;13(1):38-45. doi: 10.1097/LGT.0b013e318182cd89.

  PMID: 19098605 BACKGROUND

• Paraskevaidis E, Kalantaridou SN, Paschopoulos M, Zikopoulos K, Diakomanolis E, Dalkalitsis N, Makrydimas G, Pappa L, Malamou-Mitsi V, Agnantis NJ. Factors affecting outcome after incomplete excision of cervical intraepithelial neoplasia. Eur J Gynaecol Oncol. 2003;24(6):541-3.

  PMID: 14658599 BACKGROUND

• Fuste P, Bellosillo B, Santamaria X, Mancebo G, Marinoso L, Alameda F, Espinet B, Sole F, Serrano S, Carreras R. HPV determination in the control after LEEP due to CIN II-III: prospective study and predictive model. Int J Gynecol Pathol. 2009 Mar;28(2):120-6. doi: 10.1097/PGP.0b013e3181891459.

  PMID: 19188824 BACKGROUND

• Arbyn M, Paraskevaidis E, Martin-Hirsch P, Prendiville W, Dillner J. Clinical utility of HPV-DNA detection: triage of minor cervical lesions, follow-up of women treated for high-grade CIN: an update of pooled evidence. Gynecol Oncol. 2005 Dec;99(3 Suppl 1):S7-11. doi: 10.1016/j.ygyno.2005.07.033. Epub 2005 Sep 9.

  PMID: 16154623 BACKGROUND

• Kocken M, Uijterwaal MH, de Vries AL, Berkhof J, Ket JC, Helmerhorst TJ, Meijer CJ. High-risk human papillomavirus testing versus cytology in predicting post-treatment disease in women treated for high-grade cervical disease: a systematic review and meta-analysis. Gynecol Oncol. 2012 May;125(2):500-7. doi: 10.1016/j.ygyno.2012.01.015. Epub 2012 Jan 18.

  PMID: 22266548 BACKGROUND

• Kocken M, Helmerhorst TJ, Berkhof J, Louwers JA, Nobbenhuis MA, Bais AG, Hogewoning CJ, Zaal A, Verheijen RH, Snijders PJ, Meijer CJ. Risk of recurrent high-grade cervical intraepithelial neoplasia after successful treatment: a long-term multi-cohort study. Lancet Oncol. 2011 May;12(5):441-50. doi: 10.1016/S1470-2045(11)70078-X.

  PMID: 21530398 BACKGROUND

• Jeong NH, Lee NW, Kim HJ, Kim T, Lee KW. High-risk human papillomavirus testing for monitoring patients treated for high-grade cervical intraepithelial neoplasia. J Obstet Gynaecol Res. 2009 Aug;35(4):706-11. doi: 10.1111/j.1447-0756.2008.00989.x.

  PMID: 19751331 BACKGROUND

• Kang WD, Oh MJ, Kim SM, Nam JH, Park CS, Choi HS. Significance of human papillomavirus genotyping with high-grade cervical intraepithelial neoplasia treated by a loop electrosurgical excision procedure. Am J Obstet Gynecol. 2010 Jul;203(1):72.e1-6. doi: 10.1016/j.ajog.2010.01.063. Epub 2010 Apr 24.

  PMID: 20417477 BACKGROUND

• Rabasa J, Bradbury M, Sanchez-Iglesias JL, Guerrero D, Forcada C, Alcalde A, Perez-Benavente A, Cabrera S, Ramon-Cajal S, Hernandez J, Dinares C, Garcia A, Centeno C, Gil-Moreno A. Evaluation of the intraoperative human papillomavirus test as a marker of early cure at 12 months after electrosurgical excision procedure in women with cervical high-grade squamous intraepithelial lesion: a prospective cohort study. BJOG. 2020 Jan;127(1):99-105. doi: 10.1111/1471-0528.15932. Epub 2019 Sep 25.

  PMID: 31502397 BACKGROUND

• Torne A, Fuste P, Rodriguez-Carunchio L, Alonso I, del Pino M, Nonell R, Cardona M, Rodriguez A, Castillo P, Pahisa J, Balasch J, Ramirez J, Ordi J. Intraoperative post-conisation human papillomavirus testing for early detection of treatment failure in patients with cervical intraepithelial neoplasia: a pilot study. BJOG. 2013 Mar;120(4):392-9. doi: 10.1111/1471-0528.12072. Epub 2012 Nov 27.

  PMID: 23189989 BACKGROUND

• Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. doi: 10.1001/jama.287.16.2114.

  PMID: 11966386 BACKGROUND

• Bornstein J, Bentley J, Bosze P, Girardi F, Haefner H, Menton M, Perrotta M, Prendiville W, Russell P, Sideri M, Strander B, Tatti S, Torne A, Walker P. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol. 2012 Jul;120(1):166-72. doi: 10.1097/AOG.0b013e318254f90c.

  PMID: 22914406 BACKGROUND

Related Links

• Guía de cribado del cáncer de cuello de útero en España, 2014. Editado por Asociación Española de Patología Cervical y Colposcopia ISBN: 978-84-608-36551.

Biospecimen

Retention: SAMPLES WITH DNA

The HPV test is performed using the commercially available Hybrid Capture 2 (HC2) system (Qiagen, Gaithersburg, MD, USA), which analyses the presence of high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68). If this is positive, it is followed by the CLART-HPV2 test (Genomica, Madrid, Spain), which is a polymerase chain reaction technique that allows the detection of 35 HPV genotypes. This technique detects both high-risk HPV (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68B, 73 and 82) and low-risk HPV (6, 11, 40, 42, 43, 44, 54, 61, 62, 70, 71, 72, 81, 83, 84, 85 and 89).

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Recurrence

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Cristina Centeno Mediavilla, PhD

  Hospital Universitari Vall Hebron

  PRINCIPAL INVESTIGATOR

• Melissa Bradbury Lobato, PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• Antonio Gil Moreno, PhD

  Hospital Vall d'Hebron

  STUDY CHAIR

• Jordi Rabasa Antonijuan, PhD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Rabasa Antonijuan, PhD

CONTACT

93 489 3066; jordi2546@hotmail.com

Cristina Centeno Mediavilla, PhD

CONTACT

93 489 3066; mccenteno@vhebron.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 9, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share