Clinical trial · Observational
Vulvar Cancer Individualized Scoring System (VCISS)
Vulvar Cancer Individualized Scoring System
NCT06007625CI-TRIAL-00069005unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Machine learning-based prediction model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- cancer-specific survival (CSS) rate at 3 and 5 years
- timeFrame
- at 3 and 5 years
- description
- Primary outcome of the study will be cancer-specific survival (CSS) rate at 3 and 5 years after initiation of treatment.
Secondary outcomes (1)
- measure
- Recurrence-free survival (RFS) rate at 3 and 5 years
- timeFrame
- at 3 and 5 years
- description
- Recurrence-free survival (RFS) rate at 3 and 5 years constitutes secondary outcomes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDShetty 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. PMID 28668156
- BACKGROUNDChow 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. PMID 34435227
- BACKGROUNDMerlo S. Modern treatment of vulvar cancer. Radiol Oncol. 2020 Sep 22;54(4):371-376. doi: 10.2478/raon-2020-0053. PMID 32960779
- BACKGROUNDMadsen 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. PMID 18348142
- BACKGROUNDBrinton 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. PMID 28236455
- BACKGROUNDde 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. PMID 18192968
- BACKGROUNDHalec 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. PMID 28059099
- 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.