Vulvar Cancer Individualized Scoring System (VCISS)

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06007625

Collaborator

(none)

1,000

Enrollment

Locations

Anticipated Duration (Months)

500

Patients Per Site

45.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Cancer	Other: Machine learning-based prediction model

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:

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 not receive their treatment in the receptive centers, and if they were diagnosed with synchronous cancers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Vulvar Cancer Individualized Scoring System

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

cancer-specific survival (CSS) rate at 3 and 5 years [at 3 and 5 years]
Primary outcome of the study will be cancer-specific survival (CSS) rate at 3 and 5 years after initiation of treatment.

Secondary Outcome Measures

Recurrence-free survival (RFS) rate at 3 and 5 years [at 3 and 5 years]
Recurrence-free survival (RFS) rate at 3 and 5 years constitutes secondary outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University Main Hospital	Alexandria		Egypt	21516
2	Assiut Hospitals university	Assiut		Egypt	71511

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sherif Abdelkarim Mohammed Shazly, Sherif Abdelkarim Mohammed Shazly, Assistant lecturer, Assiut University, Middle-Eastern College of Obstetricians and Gynecologists

ClinicalTrials.gov Identifier:

NCT06007625

Other Study ID Numbers:

MCOG-VC01

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vulvar Neoplasms

Study Results

No Results Posted as of Aug 23, 2023