AzTrials
AzTrials

Vulvar CancerNCT06007625

Vulvar Cancer Individualized Scoring System (VCISS)

An observational study of Vulvar Cancer, run by Assiut University at 2 sites in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Vulvar Cancer
What is being tested?
Machine learning-based prediction model
How many people
1,000 participants
Where
2 sitesEgypt
Study dates
1 Jan 2024to 1 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Sherif Shazly contact

+4407554480388

sherif.shazly.mogge@gmail.com

Egypt2 sites

  • Alexandria University Main Hospital

    Alexandria, 21516

    Ahmed H. Ismail, 01144557597, ahmed.ismail.mogge@gmail.com

  • Assiut Hospitals university

    Asyut, 71511

    Manar M, Ahmed, 01128793950, Manar.mahran.mogge@gmail.com

Other trials in Egypt

About this study

Official title: 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.

Read the 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.
Conditions
Vulvar Cancer
Being tested
Machine learning-based prediction model
Medical subject headings
Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Machine learning-based prediction modelOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 3 and 5 years

Secondary outcomes (1)

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

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

    Measured: at 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007625
Sponsor's protocol ID
MCOG-VC01
Status last verified
Aug 2023
First submitted
17 Aug 2023
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Shetty 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.

    PubMed 28668156

  • Chow 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.

    PubMed 34435227

  • Merlo S. Modern treatment of vulvar cancer. Radiol Oncol. 2020 Sep 22;54(4):371-376. doi: 10.2478/raon-2020-0053.

    PubMed 32960779

  • Madsen 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.

    PubMed 18348142

  • Brinton 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.

    PubMed 28236455

  • de 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.

    PubMed 18192968

  • Halec 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.

    PubMed 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.

    PubMed 35565394

  • Salvo G, Odetto D, Pareja R, Frumovitz M, Ramirez PT. Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain. Int J Gynecol Cancer. 2020 Jun;30(6):873-878. doi: 10.1136/ijgc-2020-001257. Epub 2020 Apr 1.

    PubMed 32241876

  • Miljanovic-Spika I, Madunic MD, Topolovec Z, Kujadin Kenjeres D, Vidosavljevic D. PROGNOSTIC FACTORS FOR VULVAR CANCER. Acta Clin Croat. 2021 Mar;60(1):25-32. doi: 10.20471/acc.2021.60.01.04.

    PubMed 34588718

Questions about this trial

What is this clinical trial studying?

An observational study of Vulvar Cancer, run by Assiut University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sherif Shazly (+4407554480388, sherif.shazly.mogge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cancer-specific survival (CSS) rate at 3 and 5 years (time frame: at 3 and 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007625, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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