Vulvar Cancer Individualized Scoring System (VCISS)

NCT06007625UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Assiut University

Enrollment

1000

Start Date

2024-01-01

Completion Date

2024-10-01

Study Type

OBSERVATIONAL

Official Title

Vulvar Cancer Individualized Scoring System

Interventions

Machine learning-based prediction model

Conditions

Vulvar Cancer

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

cancer-specific survival (CSS) rate 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.

Time frame: at 3 and 5 years

Secondary Outcomes

Recurrence-free survival (RFS) rate at 3 and 5 years

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

Time frame: at 3 and 5 years

Locations

Alexandria University Main Hospital, Alexandria, Egypt

Assiut Hospitals university, Asyut, Egypt

Linked Papers

2021-08-25

Gynecologic tumor board: a radiologist’s guide to vulvar and vaginal malignancies

AbstractPrimary vulvar and vaginal cancers are rare female genital tract malignancies which are staged using the 2009 International Federation of Gynecology and Obstetrics (FIGO) staging. These cancers account for approximately 2,700 deaths annually in the USA. The most common histologic subtype of both vulvar and vaginal cancers is squamous cell carcinoma, with an increasing role of the human papillomavirus (HPV) in a significant number of these tumors. Lymph node involvement is the hallmark of FIGO stage 3 vulvar cancer while pelvic sidewall involvement is the hallmark of FIGO stage 3 vaginal cancer. Imaging techniques include computed tomography (CT), positron emission tomography (PET)-CT, magnetic resonance imaging (MRI), and PET-MRI. MRI is the imaging modality of choice for preoperative clinical staging of nodal and metastatic involvement while PET-CT is helpful with assessing response to neoadjuvant treatment and for guiding patient management. Determining the pretreatment extent of disease has become more important due to modern tailored operative approaches and use of neoadjuvant chemoradiation therapy to reduce surgical morbidity. Moreover, imaging is used to determine the full extent of disease for radiation planning and for evaluating treatment response. Understanding the relevant anatomy of the vulva and vaginal regions and the associated lymphatic pathways is helpful to recognize the potential routes of spread and to correctly identify the appropriate FIGO stage. The purpose of this article is to review the clinical features, pathology, and current treatment strategies for vulvar and vaginal malignancies and to identify multimodality diagnostic imaging features of these gynecologic cancers, in conjunction with its respective 2009 FIGO staging system guidelines.

Linked Investigators

Vulvar Cancer Individualized Scoring System (VCISS)