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CompletedNCT07215728AMLASUpdated Oct 10, 2025

Machine Learning Applied to EHRs Data of Patients With Sarcoma

An observational study in Sarcoma, Osteosarcoma and Ewing Sarcoma, sponsored by University of Milano Bicocca. Completed. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by University of Milano Bicocca · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Ages
21 Years and older
Sex
All
01

Study summary

Application of computational statistics and machine learning methods to data derived from electronic health records of patients diagnosed with sarcoma.

Read the detailed description

This observational, retrospective, multicenter study will be conducted on a group of patients treated at the Rizzoli Orthopedic Institute in Bologna and followed throughout their treatment. The study population includes patients of both sexes and all ages, affected by the two types of bone sarcoma typical of young people, with histologically confirmed diagnoses. The musculoskeletal tumors referred to in the study are osteosarcoma (OS) and Ewing's sarcoma (ES). Both are rare and very aggressive tumors, with a prognosis that remains unsatisfactory. These characteristics limit the possibility of conducting ad hoc studies on large case series that would allow the characterization of patients affected by these conditions in order to identify prognostic predictors. The clinical registries of specialized centers such as the Rizzoli Orthopedic Institute (IOR), which has always been a reference point for the diagnosis and treatment of sarcomas, are a source of very relevant data in this regard, allowing the collection of observational data gathered prospectively over time. The aim of this retrospective observational study is to characterize clusters of patients with different prognostic profiles and, secondarily, to identify the most predictive characteristics with respect to the prognosis of patients, applying computational intelligence algorithms using the open-source programming language R to already available data.

At the Simple Departmental Structure (SSD) of Anatomy and Pathological Histology of the Rizzoli Orthopaedic Institute (IOR), two datasets containing these variables are available and ready for use:

  • patients diagnosed with osteosarcoma at the IOR between January 1, 2003, and December 31, 2012.
  • patients diagnosed with Ewing's sarcoma at the IOR from 01/01/2003 to 31/12/2012.

Following ethical approval, access to these data will be requested, to be subsequently analyzed with computational intelligence algorithms (e.g., Random Forests) to determine the characteristics most predictive of prognosis (using a technique called "recursive feature elimination").

02

Conditions studied

  • Sarcoma
  • Osteosarcoma
  • Ewing Sarcoma

Keywords

  • sarcoma
  • osteosarcoma
  • Ewing sarcoma
  • machine learning
  • computational statistics
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 700 is above the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Information unavailable.

Eligibility criteria

Inclusion criteria: confirmed diagnosis of osteosarcoma or Ewing sarcoma between 2003 and 2012 at the IRCCS Rizzoli Orthopaedic Institute.

Exclusion criteria: diagnosis other than osteosarcoma or Ewing sarcoma and/or diagnosis made before 2003 and after 2012.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (actual)
Patient registry
No

Groups and cohorts

  • Osteosarcoma

    Data of patients diagnosed with osteosarcoma

    Other: No intervention studied

  • Ewing sarcoma

    Data of patients diagnosed with Ewing sarcoma

    Other: No intervention studied

Interventions

  • OtherNo intervention studied

    No intervention studied

06

What researchers measure

Primary outcomes

  1. Survival

    Survival of patients during the follow-up

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Fernandes K, Chicco D, Cardoso JS, Fernandes J. Supervised deep learning embeddings for the prediction of cervical cancer diagnosis. PeerJ Comput Sci. 2018 May 14;4:e154. doi: 10.7717/peerj-cs.154. eCollection 2018. PubMed 33816808 ↗
  • Chicco D, Oneto L. Computational intelligence identifies alkaline phosphatase (ALP), alpha-fetoprotein (AFP), and hemoglobin levels as most predictive survival factors for hepatocellular carcinoma. Health Informatics J. 2021 Jan-Mar;27(1):1460458220984205. doi: 10.1177/1460458220984205. PubMed 33504243 ↗
  • Chicco D, Haupt R, Garaventa A, Uva P, Luksch R, Cangelosi D. Computational intelligence analysis of high-risk neuroblastoma patient health records reveals time to maximum response as one of the most relevant factors for outcome prediction. Eur J Cancer. 2023 Nov;193:113291. doi: 10.1016/j.ejca.2023.113291. Epub 2023 Aug 19. PubMed 37708628 ↗
  • Cerono G, Melaiu O, Chicco D. Clinical Feature Ranking Based on Ensemble Machine Learning Reveals Top Survival Factors for Glioblastoma Multiforme. J Healthc Inform Res. 2023 Sep 20;8(1):1-18. doi: 10.1007/s41666-023-00138-1. eCollection 2024 Mar. PubMed 38273986 ↗
  • Chicco D, Oneto L, Cangelosi D. DBSCAN and DBCV application to open medical records heterogeneous data for identifying clinically significant clusters of patients with neuroblastoma. BioData Min. 2025 Jun 12;18(1):40. doi: 10.1186/s13040-025-00455-8. PubMed 40506780 ↗

Individual participant data

Plan to share: Undecided — If we have the authorization from the Ethical Committee of the IOR hospital, we might consider sharing the data in the future.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07215728
Lead sponsor
University of Milano Bicocca
Collaborators
IRCCS Istituto Ortopedico Rizzoli di Bologna
Responsible party
Sponsor
First posted
Oct 10, 2025
Start date
Jan 1, 2003
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012
Last update
Oct 10, 2025

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 completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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