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OpenTrials
Active, Not Recruiting

NCT Number: NCT06963385

Radiomics and Molecular Classification in Endometrial Cancer

Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Radiomic allows extracting mineable high-dimensional data from clinical images, thus providing a number of noteworthy information of the tumor tissues. We aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk The central hypothesis is that combining radiomic features might allow identifying various classes of risk for endometrial cancer. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative, and cheap method for tailor operative and postoperative treatment modality in endometrial cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Endometrium Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, 20133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(i) preoperative endometrial cancer (any histology); (ii) preoperative ultrasonographic examination; (iii) surgical treatment; (iv) age >= 18 years; (v) signed informed consent for research purposes.

Exclusion criteria

(i) consent withdraw; (ii) lack of available (tumor) tissue for molecular/genomic profiling.

Treatment and study plan

radiomics

Diagnostic Test

To correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk

Primary outcomes

  1. To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk.

    Time frame: 1-18 months

  2. Determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors.

    Time frame: 1-36 months

Secondary outcomes

  1. Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors

    Time frame: 19-36 months

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

Correlation Between RadiOmics and Molecular Classification in Endometrial Cancer (the ROME Study): a Step Forward to a Simplified Precision Medicine

Acronym: ROME

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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