Vulvar Cancer Individualized Scoring System (VCISS)

August 22, 2023 updated by: Sherif Abdelkarim Mohammed Shazly, Assiut University

Vulvar Cancer Individualized Scoring System

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer-specific survival (CSS) rate at 3 and 5 years
Time Frame: 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.
at 3 and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival (RFS) rate at 3 and 5 years
Time Frame: at 3 and 5 years
Recurrence-free survival (RFS) rate at 3 and 5 years constitutes secondary outcomes
at 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCOG-VC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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