Prognostic Value of Conization and Negative HPV After Conization in AIS and Early Stage Cervical Cancer
NCT ID: NCT06196190
Last Updated: 2024-01-09
Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-07-26
2028-07-01
Brief Summary
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Adeno-squamous carcinoma or AIS we want to examine prospectively:
1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumor in the final pathology.
2. To examine if conization in women with cervical tumor up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.
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Detailed Description
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Several studies have explored the possibility of a less aggressive approach for cervical cancer patients with low-risk early-stage disease who wish to preserve fertility. The parameters that were investigated were: the depth of invasion, tumour diameter, lymph node status positive margins in conization, positive Endo Cervical Curettage (ECC) and lymph-vascular space invasion. Those parameters have a low sensitivity and between 50-65% of women who had RH had no residual tumour in the final pathology.
Schmeler describe that woman who had conization before RH in 97.5% had no residual tumour.
A study of 92 women with cervical cancer and Adeno Carcinoma In situ (AIS) that short time after conization were negative to High-Risk HPV (HR-HPV) they had before the conization in 95% there was no residual tumour in the final pathology, or during the follow up.
To our knowledge there is no prospective study that examined the the prognostic value of Conization and negative HR- HPV typing after Conization prior to surgical intervention in Early-Stage Cervical Cancer and Adenocarcinoma in Situ.
Aim:
In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma,
Adeno-squamous carcinoma or AIS we want to examine prospectively:
1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumour in the final pathology.
2. To examine if conization in women with cervical tumour up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Post Conization HR HPV positive
Women with a Post Conization cervical test positive for HR HPV
No interventions assigned to this group
Post Conization HR HPV negative
Women with a Post Conization cervical test negative for HR HPV
No interventions assigned to this group
No Conization HR HPV positive
Women who did not go through Conization prior to surgery and had a cervical test positive for HR HPV
No interventions assigned to this group
No Conization HR HPV negative
Women who did not go through Conization prior to surgery and had a cervical test negative for HR HPV
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Yoav Siegler B.Sc. M.D
Resident at the Gynecological Oncology Department
Principal Investigators
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Yoav Siegler, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Center
Locations
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Rambam Health Care Center
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin HR, Vallejos CS, de Ruiz PA, Lima MA, Guimera N, Clavero O, Alejo M, Llombart-Bosch A, Cheng-Yang C, Tatti SA, Kasamatsu E, Iljazovic E, Odida M, Prado R, Seoud M, Grce M, Usubutun A, Jain A, Suarez GA, Lombardi LE, Banjo A, Menendez C, Domingo EJ, Velasco J, Nessa A, Chichareon SC, Qiao YL, Lerma E, Garland SM, Sasagawa T, Ferrera A, Hammouda D, Mariani L, Pelayo A, Steiner I, Oliva E, Meijer CJ, Al-Jassar WF, Cruz E, Wright TC, Puras A, Llave CL, Tzardi M, Agorastos T, Garcia-Barriola V, Clavel C, Ordi J, Andujar M, Castellsague X, Sanchez GI, Nowakowski AM, Bornstein J, Munoz N, Bosch FX; Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. doi: 10.1016/S1470-2045(10)70230-8. Epub 2010 Oct 15.
Siegler E, Reichman Y, Kugelman N, Mackuli L, Lavie O, Ostrovsky L, Shaked-Mishan P, Segev Y. Low-Risk Human Papillomavirus Types in Cervical Intraepithelial Neoplasia 2-3 and in Invasive Cervical Cancer Patients. J Low Genit Tract Dis. 2019 Oct;23(4):248-252. doi: 10.1097/LGT.0000000000000486.
Cuschieri K, Bhatia R, Cruickshank M, Hillemanns P, Arbyn M. HPV testing in the context of post-treatment follow up (test of cure). J Clin Virol. 2016 Mar;76 Suppl 1:S56-S61. doi: 10.1016/j.jcv.2015.10.008. Epub 2015 Oct 22.
Bizzarri N, Pedone Anchora L, Kucukmetin A, Ratnavelu N, Korompelis P, Carbone V, Fedele C, Bruno M, Vizzielli G, Gallotta V, De Vincenzo R, Chiantera V, Fagotti A, Fanfani F, Ferrandina G, Scambia G. Protective Role of Conization Before Radical Hysterectomy in Early-Stage Cervical Cancer: A Propensity-Score Matching Study. Ann Surg Oncol. 2021 Jul;28(7):3585-3594. doi: 10.1245/s10434-021-09695-4. Epub 2021 Feb 23.
Uppal S, Gehrig PA, Peng K, Bixel KL, Matsuo K, Vetter MH, Davidson BA, Cisa MP, Lees BF, Brunette LL, Tucker K, Stuart Staley A, Gotlieb WH, Holloway RW, Essel KG, Holman LL, Goldfeld E, Olawaiye A, Rose SL. Recurrence Rates in Patients With Cervical Cancer Treated With Abdominal Versus Minimally Invasive Radical Hysterectomy: A Multi-Institutional Retrospective Review Study. J Clin Oncol. 2020 Apr 1;38(10):1030-1040. doi: 10.1200/JCO.19.03012. Epub 2020 Feb 7.
Chacon E, Manzour N, Zanagnolo V, Querleu D, Nunez-Cordoba JM, Martin-Calvo N, Capilna ME, Fagotti A, Kucukmetin A, Mom C, Chakalova G, Shamistan A, Gil Moreno A, Malzoni M, Narducci F, Arencibia O, Raspagliesi F, Toptas T, Cibula D, Kaidarova D, Meydanli MM, Tavares M, Golub D, Perrone AM, Poka R, Tsolakidis D, Vujic G, Jedryka MA, Zusterzeel PLM, Beltman JJ, Goffin F, Haidopoulos D, Haller H, Jach R, Yezhova I, Berlev I, Bernardino M, Bharathan R, Lanner M, Maenpaa MM, Sukhin V, Feron JG, Fruscio R, Kukk K, Ponce J, Minguez JA, Vazquez-Vicente D, Castellanos T, Boria F, Alcazar JL, Chiva L; SUCCOR study group; SUCCOR study Group. SUCCOR cone study: conization before radical hysterectomy. Int J Gynecol Cancer. 2022 Feb;32(2):117-124. doi: 10.1136/ijgc-2021-002544. Epub 2022 Jan 17.
Plante M, Renaud MC, Francois H, Roy M. Vaginal radical trachelectomy: an oncologically safe fertility-preserving surgery. An updated series of 72 cases and review of the literature. Gynecol Oncol. 2004 Sep;94(3):614-23. doi: 10.1016/j.ygyno.2004.05.032.
Suri A, Frumovitz M, Milam MR, dos Reis R, Ramirez PT. Preoperative pathologic findings associated with residual disease at radical hysterectomy in women with stage IA2 cervical cancer. Gynecol Oncol. 2009 Jan;112(1):110-3. doi: 10.1016/j.ygyno.2008.09.011. Epub 2008 Oct 25.
Li X, Xia L, Chen X, Fu Y, Wu X. Simple conization and pelvic lymphadenectomy in early-stage cervical cancer: A retrospective analysis and review of the literature. Gynecol Oncol. 2020 Aug;158(2):231-235. doi: 10.1016/j.ygyno.2020.05.035. Epub 2020 Jun 6.
Costa S, Negri G, Sideri M, Santini D, Martinelli G, Venturoli S, Pelusi C, Syrjanen S, Syrjanen K, Pelusi G. Human papillomavirus (HPV) test and PAP smear as predictors of outcome in conservatively treated adenocarcinoma in situ (AIS) of the uterine cervix. Gynecol Oncol. 2007 Jul;106(1):170-6. doi: 10.1016/j.ygyno.2007.03.016. Epub 2007 May 4.
Costa S, Sideri M, Negri G, Venturoli S, Santini D, Casadio C, Sandri MT, Bucchi L. The predictive value of human papillomavirus testing for the outcome of patients conservatively treated for stage IA squamous cell cervical carcinoma. J Clin Virol. 2015 Sep;70:53-57. doi: 10.1016/j.jcv.2015.07.007. Epub 2015 Jul 8.
Siegler E, Goldberg Y, Siegler Y, Shaked-Mishan P, Mazareb S, Kugelman N, Mackuli L, Sabo E, Lavie O, Segev Y. The Association Between Clearance of Human Papillomavirus After Conization for Cervical Cancer and Absence of Cancer. J Low Genit Tract Dis. 2021 Oct 1;25(4):276-280. doi: 10.1097/LGT.0000000000000622.
Other Identifiers
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0256-23-RMB
Identifier Type: -
Identifier Source: org_study_id
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