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

NCT06196190 | Recruiting

• 1 other identifier: 0256-23-RMB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma, Adeno-squamous carcinoma or AIS we want to examine prospectively:

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

Conditions

Cervix Cancer; HPV-Related Malignancy

Outcome Measures

Primary Outcomes (1)

• Final Pathology

  Residual disease in final pathology

  1 year

Secondary Outcomes (3)

• Disease recurrence

  5 year

• Mortality

  5 year

• complications

  5 year

Study Arms (4)

Post Conization HR HPV positive

Women with a Post Conization cervical test positive for HR HPV

Post Conization HR HPV negative

Women with a Post Conization cervical test negative for HR HPV

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 Conization HR HPV negative

Women who did not go through Conization prior to surgery and had a cervical test negative for HR HPV

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma, Adeno-squamous carcinoma or AIS

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Center

Haifa, 31906, Israel

RECRUITING

Related Publications (12)

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  PMID: 20952254 BACKGROUND

• 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.

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• 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.

  PMID: 33620615 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 34369434 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cervical swap for presence of Human papillomavirus DNA

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yoav Siegler, MD

  Rambam Health Care Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoav Siegler, MD

CONTACT

+972528263054; yoav.siegler@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at the Gynecological Oncology Department

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: January 9, 2024
• Study Start: July 26, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

IL (1)