Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District (RAC)

March 7, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District - Observational Study With Retrospective and Prospective Phase

The goal of this observational study is to collect structured data about diagnosis, treatment and follow-up of rare and highly complex neoplasms.

The study has a rerospective part that will consist in gathering data on patients accessing IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola from 01/01/2000 to 28/09/2017 and a prospective one ranging from 29/09/2017 to 31/12/2025.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Oncology Unit, IRCCS AOUBO Policlinico di S. Orsola
        • Contact:
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Thoracic Surgery Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients over 18 years of age with a diagnosis of histologically proven rare or highly complex malignant tumour

Description

Inclusion Criteria:

  • patients with histologic diagnosis of rare or highly complex malignant neoplasm
  • informed consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of different malignant rare neoplasms
Time Frame: Throughout the lenght of study, an average of 10 years
Description of types of tumours
Throughout the lenght of study, an average of 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate (RR)
Time Frame: Throughout the lenght of study, an average of 10 years
Response rate to different treatments (surgery, drugs)
Throughout the lenght of study, an average of 10 years
Local recurrence rate
Time Frame: Throughout the lenght of study, an average of 10 years
Incidence of local recurrence
Throughout the lenght of study, an average of 10 years
Progression-free survival (PFS)
Time Frame: Throughout the lenght of study, an average of 10 years
Progression-free survival (PFS) assessed for different types of rare malignant neoplasms
Throughout the lenght of study, an average of 10 years
Overall survival (OS)
Time Frame: Throughout the lenght of study, an average of 10 years
OS assessed for different types of rare malignant neoplasms
Throughout the lenght of study, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Maria A Pantaleo, MD, Oncology Unit, IRCCS AOUBO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAC - 1058/2020/OSS/AOUBo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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