NCT06872853

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2017

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

8.2 years

First QC Date

March 7, 2025

Last Update Submit

March 7, 2025

Conditions

Rare Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Incidence of different malignant rare neoplasms

    Description of types of tumours

    Throughout the lenght of study, an average of 10 years

Secondary Outcomes (4)

  • Response rate (RR)

    Throughout the lenght of study, an average of 10 years

  • Local recurrence rate

    Throughout the lenght of study, an average of 10 years

  • Progression-free survival (PFS)

    Throughout the lenght of study, an average of 10 years

  • Overall survival (OS)

    Throughout the lenght of study, an average of 10 years

Interventions

diagnosis, surgery, drugs for rare neoplasmsOTHER

diagnostic and surgical procedures, drugs (pharmacological active substance, dose, regimen)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oncology Unit, IRCCS AOUBO Policlinico di S. Orsola

Bologna, BO, 40138, Italy

RECRUITING

Thoracic Surgery Unit

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, OperativePharmaceutical Preparations

Study Officials

  • Maria A Pantaleo, MD

    Oncology Unit, IRCCS AOUBO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria A Pantaleo, MD

CONTACT

+39 051 214maria.pantaleo@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 12, 2025

Study Start

September 29, 2017

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)