Evaluation of Rare and Complex Tumours of the Thoraco-Abd... | NCT06872853

Studies
Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District

NCT06872853

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Mar 12, 2025Actual

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Rare Malignant Neoplasm

Interventions

diagnosis, surgery, drugs for rare neoplasms

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2017Actual

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 7, 2025

First Submission Date that Met QC Criteria

Mar 7, 2025

First Posted Date

Mar 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2025

Last Update Posted Date

Mar 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diagnosis, surgery, drugs for rare neoplasms	Other	diagnostic and surgical procedures, drugs (pharmacological active substance, dose, regimen)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Response rate (RR)	Response rate to different treatments (surgery, drugs)	Throughout the lenght of study, an average of 10 years
Local recurrence rate	Incidence of local recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria A Pantaleo, MD	Contact	+39 051 214	4043	maria.pantaleo@unibo.it

Overall Officials

Name	Affiliation	Role
Maria A Pantaleo, MD	Oncology Unit, IRCCS AOUBO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncology Unit, IRCCS AOUBO Policlinico di S. Orsola	Recruiting	Bologna	BO	40138	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D004364	Pharmaceutical Preparations

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided