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Status unknownNCT05161949ATENAUpdated Dec 17, 2021

Artificial inTelligence in eNdometriosis-related ovArian Cancer and Precision Surgery in eNdometriosis-related ovArian Cancer

An observational study in Patients With Suspected Ovarian Carcinoma and Non Oncological Patients or With Endometriosis, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 90 Years
Sex
Female
01

Study summary

Endometriosis (EMS) is a chronic, invaliding, inflammatory gynaecological condition affecting 10-15% of women in reproductive age. EMS is characterized by lesions of endometrial-like tissue outside the uterus involving pelvic peritoneum and ovaries. In addition, distant foci are sometimes observed. Unfortunately, the aetiology of the EMS is little known. Although non-malignant, EMS shares similar features with cancer, such as development of local and distant foci, resistance to apoptosis and invasion of other tissues with subsequent damage to the target organs. Moreover, patients with EMS (particularly ovarian EMS) showed high risk (about 3 to 10 times) of developing epithelial ovarian cancer (EOC). Epidemiologic, morphological and molecular studies reported endometrioma as the precursor of EOC, including clear cell (CCC) endometrioid carcinoma which are both called "EMS-related ovarian carcinoma (EROC)". To date, it remains unclear why benign EMS causes malignant transformation. This multi-step process, unlike high-grade serous carcinomas, offers the possibility to identify the carcinoma precursors enabling an early diagnosis and in the early stages of the disease.

EOC is the most lethal female gynecological cancer with 25% 5-year overall survival (OS), due to the lack of effective screening tools, and rapidly spreads over the entire peritoneal surface (carcinosis) thus involving all abdominal organs. Diagnosis and clinical staging of EOC is currently performed by qualitative image evaluation although the sensitivity/specificity is suboptimal. To date, diagnostic, staging, and prognostic factors are strongly correlated with subjective assessment training and clinician experience.

Genomic analysis based on Next Generation Sequencing (NGS) has revealed the presence of cancer-associated gene mutations in EMS. Moreover, the chronic inflammatory process of EMS involves many factors, such as hormones, cytokines, glycoproteins, and angiogenic factors, which are expected to become early EMS biomarkers.

A promising new branch of cancer research is the use of artificial intelligence (AI) to recognize new image patterns and texture and/or detecting novel biomarkers to improve the early identification of EROC patients. AI has never been used for EROC and we want to investigate whether these methods/techniques can support and even improve current diagnostics and risk assessment. AI will be used to construct a new 3D risk assessment model based on images and volume of interest

02

Conditions studied

  • Patients With Suspected Ovarian Carcinoma
  • Non Oncological Patients or With Endometriosis

Keywords

  • endometriosis
  • ovarian cancer
  • artificial intelligence
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 240 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients aged between 18 and 90 years, with clinical and radiological suspicion of ovarian cancer, eligible for surgery followed in the clinical care path at the U.O.C. Oncological Gynecology-IRCCS A.O.U of Bologna (study group) and patients aged 18 to 90 years with clinical and radiological suspicion of endometriosis or healthy (control group)

Inclusion criteria

  • age>18
  • Suspected diagnosis of epithelial ovarian cancer
  • Patients eligible for surgery
  • radiological imaging available
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients with previous different malignancies
  • Patients with previous chemotherapeutic treatment
  • Patients with previous pelvic radiotherapeutic treatment
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • group 1

    200 patients with suspected ovarian cancer

  • group 2

    40 non oncological patients of witch 20 with endometriosis

06

What researchers measure

Primary outcomes

  1. development of a diagnostic and prognostic model based on the use of artificial intelligence

    development of a diagnostic and prognostic model based on the use of artificial intelligence in patients suffering from ovarian cancer related to endometriosis through the collection of all available information (clinical, pathological, molecular, genetic, radiomic data)

    Time frame: 2 years

Secondary outcomes

  1. Correlation of specific features with clinical characteristic

    Correlation of the histopathological features, immuno-phenotypic and molecular alterations present in epithelial ovarian tumors, in particular in associated endometriosis related- ovarian tumors, using an immunohistochemical profile and an NGS panel * evaluation of the miRNA expression profile in endometriosis related- ovarian tumors * identification and validation of radiomic features indicative of endometriosis related- ovarian tumors * build a three-dimensional map of the lesions in order to distinguish the tumor areas to be removed during surgery while preserving the organs not affected by the tumor pathology

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • IRCCS- Azienda Ospedaliera-Universitaria di Bologna
    Bologna, Bo 40138, Italy
    • Anna Myriam Perrone, MD · Contact · myriam.perrone@unibo.it · +39 051 2144392
    • Anna Myriam Perrone · Principal investigator
    • Pierandrea De IAco · Principal investigator
    • Lidia Strigari · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05161949
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Anna Myriam Perrone (MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna) — Principal investigator
First posted
Dec 17, 2021
Start date
Nov 29, 2021
Primary completion
Jul 30, 2023 (estimated)
Completion
Nov 28, 2023 (estimated)
Last update
Dec 17, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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