Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-17
Brief Title:
Vulvar Cancer Individualized Scoring System VCISS
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Vulvar Cancer Individualized Scoring System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 diseases 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 23
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 andor 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
It comes the fourth among the commonest gynecological cancers and tends to affect women after menopause with a median age of 68 years 23
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None