HSIL, High Grade Squamous Intraepithelial LesionsNCT04190472
Intraoperative HPV Testing Evaluation
An observational study of HSIL, High Grade Squamous Intraepithelial Lesions and Recurrence, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- HSIL, High Grade Squamous Intraepithelial Lesions, Recurrence
- What is being tested?
- IOP HPV test
- How many people
- 1,553 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intraoperative HPV Testing Evaluation: Multicenter Prospective Cohort Study
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.
Read the detailed description
Background:
High-Grade Intraepithelial Lesion/Cervical Intraepithelial Neoplasia grade 2-3 (HSIL/CIN2-3) is a premalignant cervical lesion caused by persistent high-risk Human papillomavirus (HPV) infection [1]. It is estimated that approximately 54,000 women in Spain are annually diagnosed with HSIL/CIN2-3, which represents a significant economic burden for the national health system [2]. Electrosurgical excision procedure (LEEP) is the standard treatment of HSIL/CIN2-3 [3,4]. In Spain, current national guidelines recommend control after LEEP at 6, and 24 months [5,6,7]. The HPV test is a sensitive marker of cervical cancer risk and it has been incorporated, with cytology, in the follow-up of squamous cervical intraepithelial lesion after a LEEP [8,9,10].
We recently showed that an HPV test performed intraoperatively (IOP-HPV) has a strong association with recurrent disease as well as a good diagnostic recurrence efficiency at 12 months, similar than the test performed at 6 months. Thus, IOP-HPV test could be feasible and useful to identify treatment failure earlier than conventional strategies [11]. These results are similar to those previously observed by other authors [12].
However, one of the limitations of previous studies was the sample size of patients to achieve greater statistical power and perform a non-inferiority study.
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 LEEP.
Material and methods
This is a multicenter prospective cohort study that will include patients diagnosed with HSIL/CIN2-3. This study will be carried out at the Hospital Vall d'Hebron in Barcelona (organizing center) and other National centers from June 2020 to June 2024. All patients will undergo a HPV test 3 months prior to treatment and will be followed for a period of 24 months.
Cytology samples will be interpreted by an experienced pathologist following the Bethesda System [13]. HPV test will be performed using the commercially available Hybrid Capture 2 (HC2) system. If this is positive, it will be followed by the CLART-HPV2 test, a PCR technique that will allow the detection of 35 HPV genotypes.
Colposcopy will be performed using a colposcope Olympus 500 after preparing the cervix with 5% acetic acid and lugol solution. Colposcopy findings will be described following the criteria of the International Federation for Cervical Pathology and Colposcopy (IFCPC) [14].
Prior to LEEP, the abnormal area will be delimited by acetic acid and iodinated lugol, a colposcopy will be performed prior to the application of 1 ml of 2% mepivacaine to each quadrant of the cervix.
The entire pathological area will be removed next to the transformation zone (TZ), followed by selective coagulation of the surgical bed by diathermic coagulation ball. Immediately after the LEEP, a cervical sample will be taken for the IOP-HPV test. At the end of the procedure an ECC will be performed using a Novak curette.
The cervical specimen will be processed in a standardized way: after staining with ink the surfaces (or the margins) of the piece, a paraffin block will be obtained from which a minimum of 12 sections, of the 4 quadrants will be examined. A margin will be considered affected if the lesion reaches the margin or is within 1mm.
After surgery, the follow-up will be performed according to the National Guidelines Recommendations5,6,7. Visits will be scheduled according to the margin status of the LEEP specimen: If the margins are negative, the patient will be reviewed at 6, 12 and 24 months with cytology, HPV test and colposcopy. If they are positive, a visit will be added 4 months after the procedure where an additional cervical cytology will be taken.
Patients with abnormal cytology (LSIL+) or abnormal colposcopy will undergo a CGB. When the TZ is not completely visible or no colposcopic abnormalities are identified, an ECC with Novak curette will also be performed.
High-grade recurrence will be considered either when the CGB confirmes HSIL/CIN2-3 or when the ECC shows HSIL.The criteria to perform a second treatment will be the histological confirmation of HSIL/CIN2-3 during the follow-up.
- Being tested
- IOP HPV test
- Keywords
- HSIL, Follow-up, LEEP
- Medical subject headings
- Squamous Intraepithelial Lesions, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP HPV testDiagnostic test
Immediately after the LEEP, a cervical sample was taken for the IOP-HPV test
| Study group | Role | What they receive |
|---|---|---|
| IOP VPH test | Immediately after the LEEP, a cervical sample is token for the IOP-HPV test Receives: Diagnostic Test: IOP HPV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months of follow-up after LEEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HSIL, High Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,553 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Centeno Mediavilla, PhD, Principal investigator, Hospital Universitari Vall HebronMelissa Bradbury Lobato, PhD, Principal investigator, Hospital Vall d'HebronAntonio Gil Moreno, PhD, Study chair, Hospital Vall d'HebronJordi Rabasa Antonijuan, PhD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190472
- Sponsor's protocol ID
- IOP VPH IOP Protocol
- Status last verified
- Apr 2020
- First submitted
- 29 Nov 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10863633Castellsague 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.
PubMed 19098605Paraskevaidis 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.
PubMed 14658599Fuste 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.
PubMed 19188824Arbyn 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.
PubMed 16154623Kocken 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.
PubMed 22266548Kocken 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.
PubMed 21530398Jeong 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.
PubMed 19751331Kang 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.
PubMed 20417477Rabasa 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.
PubMed 31502397Torne 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.
PubMed 23189989Solomon 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.
PubMed 11966386Bornstein 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.
PubMed 22914406
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative HPV Testing Evaluation: Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04190472
- Acronym / sponsor ID
- IOP VPH IOP Protocol
- Keywords
- HSIL, Follow-up, LEEP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,553 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
High-Grade Intraepithelial Lesion/Cervical Intraepithelial Neoplasia grade 2-3 (HSIL/CIN2-3) is a premalignant cervical lesion caused by persistent high-risk Human papillomavirus (HPV) infection [1]. It is estimated that approximately 54,000 women in Spain are annually diagnosed with HSIL/CIN2-3, which represents a significant economic burden for the national health system [2]. Electrosurgical excision procedure (LEEP) is the standard treatment of HSIL/CIN2-3 [3,4]. In Spain, current national guidelines recommend control after LEEP at 6, and 24 months [5,6,7]. The HPV test is a sensitive marker of cervical cancer risk and it has been incorporated, with cytology, in the follow-up of squamous cervical intraepithelial lesion after a LEEP [8,9,10].
We recently showed that an HPV test performed intraoperatively (IOP-HPV) has a strong association with recurrent disease as well as a good diagnostic recurrence efficiency at 12 months, similar than the test performed at 6 months. Thus, IOP-HPV test could be feasible and useful to identify treatment failure earlier than conventional strategies [11]. These results are similar to those previously observed by other authors [12].
However, one of the limitations of previous studies was the sample size of patients to achieve greater statistical power and perform a non-inferiority study.
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 LEEP.
Material and methods
This is a multicenter prospective cohort study that will include patients diagnosed with HSIL/CIN2-3. This study will be carried out at the Hospital Vall d'Hebron in Barcelona (organizing center) and other National centers from June 2020 to June 2024. All patients will undergo a HPV test 3 months prior to treatment and will be followed for a period of 24 months.
Cytology samples will be interpreted by an experienced pathologist following the Bethesda System [13]. HPV test will be performed using the commercially available Hybrid Capture 2 (HC2) system. If this is positive, it will be followed by the CLART-HPV2 test, a PCR technique that will allow the detection of 35 HPV genotypes.
Colposcopy will be performed using a colposcope Olympus 500 after preparing the cervix with 5% acetic acid and lugol solution. Colposcopy findings will be described following the criteria of the International Federation for Cervical Pathology and Colposcopy (IFCPC) [14].
Prior to LEEP, the abnormal area will be delimited by acetic acid and iodinated lugol, a colposcopy will be performed prior to the application of 1 ml of 2% mepivacaine to each quadrant of the cervix.
The entire pathological area will be removed next to the transformation zone (TZ), followed by selective coagulation of the surgical bed by diathermic coagulation ball. Immediately after the LEEP, a cervical sample will be taken for the IOP-HPV test. At the end of the procedure an ECC will be performed using a Novak curette.
The cervical specimen will be processed in a standardized way: after staining with ink the surfaces (or the margins) of the piece, a paraffin block will be obtained from which a minimum of 12 sections, of the 4 quadrants will be examined. A margin will be considered affected if the lesion reaches the margin or is within 1mm.
After surgery, the follow-up will be performed according to the National Guidelines Recommendations5,6,7. Visits will be scheduled according to the margin status of the LEEP specimen: If the margins are negative, the patient will be reviewed at 6, 12 and 24 months with cytology, HPV test and colposcopy. If they are positive, a visit will be added 4 months after the procedure where an additional cervical cytology will be taken.
Patients with abnormal cytology (LSIL+) or abnormal colposcopy will undergo a CGB. When the TZ is not completely visible or no colposcopic abnormalities are identified, an ECC with Novak curette will also be performed.
High-grade recurrence will be considered either when the CGB confirmes HSIL/CIN2-3 or when the ECC shows HSIL.The criteria to perform a second treatment will be the histological confirmation of HSIL/CIN2-3 during the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOP VPH test | – | Diagnostic Test: IOP HPV testImmediately after the LEEP, a cervical sample is token for the IOP-HPV test |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOP HPV testImmediately after the LEEP, a cervical sample was taken for the IOP-HPV test | Diagnostic test | IOP VPH test |
Primary outcome
Intraoperatory HPV testing evaluation: non- inferior study of diagnostic utility of HSIL/CIN2-3 recurrence as 6-months HPV test.
Time frame: 24 months of follow-up after LEEP
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Background: PubMed 10863633Pinto 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.
- Background: PubMed 19098605Castellsague 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.
- Background: PubMed 14658599Paraskevaidis 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.
- Background: PubMed 19188824Fuste 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.
- Background: PubMed 16154623Arbyn 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.
- Background: PubMed 22266548Kocken 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.
- Background: PubMed 21530398Kocken 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.
- Background: PubMed 19751331Jeong 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.
- Background: PubMed 20417477Kang 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.
- Background: PubMed 31502397Rabasa 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.
- Background: PubMed 23189989Torne 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.
- Background: PubMed 11966386Solomon 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Centeno Mediavilla, PhD principal investigator
Hospital Universitari Vall Hebron
Melissa Bradbury Lobato, PhD principal investigator
Hospital Vall d'Hebron
Antonio Gil Moreno, PhD study chair
Hospital Vall d'Hebron
Questions about this trial
What is this clinical trial studying?
An observational study of HSIL, High Grade Squamous Intraepithelial Lesions and Recurrence, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi Rabasa Antonijuan, PhD (93 489 3066, jordi2546@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperatory HPV testing evaluation: non- inferior study of diagnostic utility of HSIL/CIN2-3 recurrence as 6-months HPV test. (time frame: 24 months of follow-up after LEEP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190472, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.