Clinical trial NCT06007625: Vulvar Cancer Individualized Scoring System (VCISS)
Official title: Vulvar Cancer Individualized Scoring System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vulvar Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women who will be diagnosed with primary vulvar cancer at any stage, of all histological types and grades eligible for the study

Brief summary: This study aims to develop a machine learning-based prediction model for patients with vulvar cancer. This model will utilize patient characteristics and disease features to determine the disease's prognosis. The scoring system will also include management information to facilitate prediction of clinical outcomes of different management strategies and potential management that would yield the best prognosis.

Detailed description: Vulvar cancer (VC) is a relatively rare gynecological cancer accounting for 5-8% of all cases \[1\].

It comes the fourth among the commonest gynecological cancers and tends to affect women after menopause with a median age of 68 years \[2,3\].

Risk factors include cervical intraepithelial neoplasia, prior history of cervical cancer, smoking, lichen sclerosus, and immunodeficiency syndromes \[4-5\]. As squamous cell carcinoma is considered the most common type of VC, there are two potential pathogenic pathways for squamous cell carcinoma of the vulva include chronic inflammatory processes and human papillomavirus (HPV) infection \[6-7\].

While VC may be asymptomatic, most cases are present with bleeding, discharge, vulvar mass, ulcer and/or pruritis. Furthermore, it can be presented by a groin mass which reflects inguinal lymph node involvement. VC may be confined to the primary site in 59% of cases while 30% and 6% of cases spread to regional lymph nodes and distant areas, respectively \[8\].

FIGO staging is considered the standard classification system that determines prognosis and management of newly diagnosed VC. However, there are numerous gaps in the current staging system that would limit full interpretation of prognosis and management guidance \[9\]. Although staging system primarily determines disease prognosis, the staging system does not consider all prognostic factors, such as disease stage and histopathology. In fact, factors other than lymph node metastasis may have a stronger predictive influence such as the severity of the disease, age, histologic type and adjuvant radiotherapy and chemotherapy \[10\].

Development of a prognostic and decision-making system, based on comprehensive inclusion of individual patient and disease characteristics, would facilitate accurate prediction of disease prognosis and determination of individualized management strategy

A retrospective multicenter cohort study will be conducted among at least 6 European gynecologic oncology centers.

Inclusion Criteria:

1. Women diagnosed with Vulvar cancer and treated at collaborating centers between January 1st, 2008, and December 31st, 2017.
2. Women aged 18 years old or older, complete follow-up on for at least 3 years, unless censored by mortality.

Exclusion criteria:

1. Women will be excluded from the study if there were lost to follow-up before 3 years post-treatment.
2. If the patient did not not receive their treatment in the receptive centers, and if they were diagnosed with synchronous cancers.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with Vulvar cancer and treated at collaborating centers between January 1st, 2008, and December 31st, 2017
* women aged 18 years old or older, complete follow-up on for at least 3 years, unless censored by mortality.

Exclusion Criteria:

* Women will be excluded from the study if there were lost to follow-up before 3 years post-treatment
* If the patient did not receive their treatment in the receptive centers
* If the patient were diagnosed with synchronous cancers

Primary outcomes:
measure: cancer-specific survival (CSS) rate at 3 and 5 years
timeFrame: at 3 and 5 years
Secondary outcomes:
measure: Recurrence-free survival (RFS) rate at 3 and 5 years
timeFrame: at 3 and 5 years
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Main Hospital
city: Assiut
country: Egypt
facility: Assiut Hospitals university
Study officials:
References:
citation: Shetty AS, Menias CO. MR Imaging of Vulvar and Vaginal Cancer. Magn Reson Imaging Clin N Am. 2017 Aug;25(3):481-502. doi: 10.1016/j.mric.2017.03.013. Epub 2017 May 27.
citation: Chow L, Tsui BQ, Bahrami S, Masamed R, Memarzadeh S, Raman SS, Patel MK. Gynecologic tumor board: a radiologist's guide to vulvar and vaginal malignancies. Abdom Radiol (NY). 2021 Dec;46(12):5669-5686. doi: 10.1007/s00261-021-03209-2. Epub 2021 Aug 25.
citation: Merlo S. Modern treatment of vulvar cancer. Radiol Oncol. 2020 Sep 22;54(4):371-376. doi: 10.2478/raon-2020-0053.
citation: Madsen BS, Jensen HL, van den Brule AJ, Wohlfahrt J, Frisch M. Risk factors for invasive squamous cell carcinoma of the vulva and vagina--population-based case-control study in Denmark. Int J Cancer. 2008 Jun 15;122(12):2827-34. doi: 10.1002/ijc.23446.
citation: Brinton LA, Thistle JE, Liao LM, Trabert B. Epidemiology of vulvar neoplasia in the NIH-AARP Study. Gynecol Oncol. 2017 May;145(2):298-304. doi: 10.1016/j.ygyno.2017.02.030. Epub 2017 Feb 22.
citation: de Koning MN, Quint WG, Pirog EC. Prevalence of mucosal and cutaneous human papillomaviruses in different histologic subtypes of vulvar carcinoma. Mod Pathol. 2008 Mar;21(3):334-44. doi: 10.1038/modpathol.3801009. Epub 2008 Jan 11.
citation: Halec G, Alemany L, Quiros B, Clavero O, Hofler D, Alejo M, Quint W, Pawlita M, Bosch FX, de Sanjose S. Biological relevance of human papillomaviruses in vulvar cancer. Mod Pathol. 2017 Apr;30(4):549-562. doi: 10.1038/modpathol.2016.197. Epub 2017 Jan 6.
citation: Virarkar M, Vulasala SS, Daoud T, Javadi S, Lall C, Bhosale P. Vulvar Cancer: 2021 Revised FIGO Staging System and the Role of Imaging. Cancers (Basel). 2022 Apr 30;14(9):2264. doi: 10.3390/cancers14092264.
citation: Salvo G, Odetto D, Pareja R, Frumovitz M, Ramirez PT. Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain. Int J Gynecol Cancer. 2020 Jun;30(6):873-878. doi: 10.1136/ijgc-2020-001257. Epub 2020 Apr 1.
citation: Miljanovic-Spika I, Madunic MD, Topolovec Z, Kujadin Kenjeres D, Vidosavljevic D. PROGNOSTIC FACTORS FOR VULVAR CANCER. Acta Clin Croat. 2021 Mar;60(1):25-32. doi: 10.20471/acc.2021.60.01.04.