Prognostic Value of Conization and Negative HPV After Conization in AIS and Early Stage Cervical Cancer

Официальное название

The Prognostic Value of Conization and Negative HPV Typing After Conization Prior to Surgical Intervention in Adenocarcinoma in Situ and Early Stage Cervical Cancer

Обзор

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 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.

Подробное описание

The treatment of invasive cervical cancer is tailored according to the FIGO recommendations. The standard treatment for women with early-stage, (IA2-IB1) cervical cancer is simple or Radical Hysterectomy (RH) and in women with Adenocarcinoma in Situ hysterectomy is recommended when they finish their fertility program .A Few studies describe that conization before Radical Hysterectomy in women with cervical cancer stage I B 1 ( tumour up to 4 cm according to FIGO 2009 ) , are in correlation with better prognosis , Bizzari describe women that had conization before RH had better 5 year survival. Uppal report that those women have less recurrence, OR of 0.4 compared with women without conization. Chacon summarize SUCCOR study, a multi center study that collected data about 374 women with cervical cancer Stage I B 1 according to FIGO 2009 -tumour up to 4 cm .187 women had conization before RH and 187 had RH without conization. Women that had conization had 65% less recurrence 'and 75% les mortality.

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.

Первичные конечные точки

• Final Pathology [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Disease recurrence [Срок оценки: 5 year]
• Mortality [Срок оценки: 5 year]
• complications [Срок оценки: 5 year]

Критерии участия

Критерии включения

Age Range: 18-85 years old Cervical cancer stage I B 2(Tumor up to 4 cm FIGO 2018) AIS HPV types before and after conization

Критерии исключения

Pregnant women under 18 years old. Women who refused to continue to be in study. Women that data about HPV types , final pathology or complication are missing.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Израиль · 1 центр

• Rambam Health Care Center — Haifa

Публикации

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• 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, Ja PMID 35039455
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Идентификаторы

NCT: NCT06196190 · 0256-23-RMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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