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NCT Number: NCT06196190

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Rambam Health Care Center

Haifa, 31906, Israel

Location status: Recruiting

Location contact

Yoav Siegler, MD

CONTACT

[email protected]

About this study

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:

  • 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.
  • To examine if conization in women with cervical tumour up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Final Pathology

    Time frame: 1 year

    Residual disease in final pathology

Secondary outcomes

  1. Disease recurrence

    Time frame: 5 year

    number of months until Disease recurrence

  2. Mortality

    Time frame: 5 year

    mortality rate during the study between the groups

  3. complications

    Time frame: 5 year

    major complications

Study contacts

Contact information is provided by the study sponsor or research team.

Yoav Siegler, MD

CONTACT

[email protected]

+972528263054

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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