Rare Malignant NeoplasmRACNCT06872853
Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District
An observational study of Rare Malignant Neoplasm, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rare Malignant Neoplasm
- What is being tested?
- diagnosis, surgery, drugs for rare neoplasms
- How many people
- 1,100 participants
- Where
- 2 sitesItaly
- Study dates
- 29 Sep 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients over 18 years of age with a diagnosis of histologically proven rare or highly complex malignant tumour
Who may be able to join
- patients with histologic diagnosis of rare or highly complex malignant neoplasm
- informed consent
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Oncology Unit, IRCCS AOUBO Policlinico di S. Orsola
Bologna, BO, 40138
Maria Pantaleo, MD, 051214 ext. 4043, maria.pantaleo@unibo.it
- Recruiting
Thoracic Surgery Unit
Bologna, BO, 40138
Niccolò Daddi, MD, +39051214 ext. 4982, niccolo.daddi@unibo.it
About this study
Official title: 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.
- Conditions
- Rare Malignant Neoplasm
- Being tested
- diagnosis, surgery, drugs for rare neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis, surgery, drugs for rare neoplasmsOther
diagnostic and surgical procedures, drugs (pharmacological active substance, dose, regimen)
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of different malignant rare neoplasms
Description of types of tumours
Measured: Throughout the lenght of study, an average of 10 years
Secondary outcomes (4)
Response rate (RR)
Response rate to different treatments (surgery, drugs)
Measured: Throughout the lenght of study, an average of 10 years
Local recurrence rate
Incidence of local recurrence
Measured: Throughout the lenght of study, an average of 10 years
Progression-free survival (PFS)
Progression-free survival (PFS) assessed for different types of rare malignant neoplasms
Measured: Throughout the lenght of study, an average of 10 years
Overall survival (OS)
OS assessed for different types of rare malignant neoplasms
Measured: Throughout the lenght of study, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start29 Sep 2017
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria A Pantaleo, MD, Principal investigator, Oncology Unit, IRCCS AOUBO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872853
- Sponsor's protocol ID
- RAC - 1058/2020/OSS/AOUBo
- Acronym
- RAC
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District - Observational Study With Retrospective and Prospective Phase
- ClinicalTrials.gov ID
- NCT06872853
- Acronym / sponsor ID
- RAC / RAC - 1058/2020/OSS/AOUBo
- Conditions
- Rare Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients over 18 years of age with a diagnosis of histologically proven rare or highly complex malignant tumour
Key inclusion criteria (2 listed)
- patients with histologic diagnosis of rare or highly complex malignant neoplasm
- informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis, surgery, drugs for rare neoplasmsdiagnostic and surgical procedures, drugs (pharmacological active substance, dose, regimen) | Other | – |
Primary outcome
Incidence of different malignant rare neoplasms
Time frame: Throughout the lenght of study, an average of 10 years
Description of types of tumours
4 secondary outcomes
Response rate (RR)
Time frame: 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
Progression-free survival (PFS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria A Pantaleo, MD principal investigator
Oncology Unit, IRCCS AOUBO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Malignant Neoplasm, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria A Pantaleo, MD (+39 051 214 ext. 4043, maria.pantaleo@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of different malignant rare neoplasms (time frame: Throughout the lenght of study, an average of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.