Malignant Bone TumorINSPECTORNCT07113301
Incisional Biopsy Versus Core-needle Biopsy in Bone Tumors Analysis
An observational study of Malignant Bone Tumor, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The investigators will collect data of patients with high suspicion of malignant bone tumor based on radiological imaging who underwent/will undergo both core needle biopsy and incisional biopsy for diagnostic confirmation by histological examination. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Malignant Bone Tumor
- What is being tested?
- incisional or core-needle biopsy for tumor diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 5 Nov 2024to 31 Dec 2027
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female patients surgically treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027
Who may be able to join
- Age ≥ 2 years
- Patients with high suspicion of malignant bone tumor who underwent/will undergo both core needle biopsy and incisional biopsy
- Male and female patients treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027
- Patients with available clinical and imaging data
Who cannot join
- Patients with bone tumor who underwent/will undergo only core needle biopsy
- Patients with bone tumor who underwent/ will undergo only incisional biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Agreement in Histological Findings Between Core Needle and Incisional Biopsies
The investigators will collect data of patients with high suspicion of malignant bone tumor based on radiological imaging who underwent/will undergo both core needle biopsy and incisional biopsy for diagnostic confirmation by histological examination.
From 01/01/2015 to the approval date of this study: retrospective study; from the approval date of this study to 31/12/2027: prospective study. the investigators expect to collect data from a total of 72 patients: approximately 30 patients for the retrospective study and 42 for the prospective study. A review will be made from the medical records, radiological imaging, and histological data of partecipants.
- Conditions
- Malignant Bone Tumor
- Being tested
- incisional or core-needle biopsy for tumor diagnosis
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incisional or core-needle biopsy for tumor diagnosisProcedure or surgery
incisional or core-needle biopsy for tumor diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start5 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Bone TumorStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113301
- Sponsor's protocol ID
- INSPECTOR
- Acronym
- INSPECTOR
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kasraeian S, Allison DC, Ahlmann ER, Fedenko AN, Menendez LR. A comparison of fine-needle aspiration, core biopsy, and surgical biopsy in the diagnosis of extremity soft tissue masses. Clin Orthop Relat Res. 2010 Nov;468(11):2992-3002. doi: 10.1007/s11999-010-1401-x.
PubMed 20512437Mitsuyoshi G, Naito N, Kawai A, Kunisada T, Yoshida A, Yanai H, Dendo S, Yoshino T, Kanazawa S, Ozaki T. Accurate diagnosis of musculoskeletal lesions by core needle biopsy. J Surg Oncol. 2006 Jul 1;94(1):21-7. doi: 10.1002/jso.20504.
PubMed 16788939Errani C, Traina F, Perna F, Calamelli C, Faldini C. Current concepts in the biopsy of musculoskeletal tumors. ScientificWorldJournal. 2013 Jun 5;2013:538152. doi: 10.1155/2013/538152. Print 2013.
PubMed 23844403
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Agreement in Histological Findings Between Core Needle and Incisional Biopsies
- ClinicalTrials.gov ID
- NCT07113301
- Acronym / sponsor ID
- INSPECTOR / INSPECTOR
- Conditions
- Malignant Bone Tumor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 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 investigators will collect data of patients with high suspicion of malignant bone tumor based on radiological imaging who underwent/will undergo both core needle biopsy and incisional biopsy for diagnostic confirmation by histological examination.
From 01/01/2015 to the approval date of this study: retrospective study; from the approval date of this study to 31/12/2027: prospective study. the investigators expect to collect data from a total of 72 patients: approximately 30 patients for the retrospective study and 42 for the prospective study. A review will be made from the medical records, radiological imaging, and histological data of partecipants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients surgically treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027
Key inclusion criteria (4 listed)
- Age ≥ 2 years
- Patients with high suspicion of malignant bone tumor who underwent/will undergo both core needle biopsy and incisional biopsy
- Male and female patients treated at Rizzoli Orthopaedic Institute from the approval date of this study to 31/12/2027
- Patients with available clinical and imaging data
Key exclusion criteria (2 listed)
- Patients with bone tumor who underwent/will undergo only core needle biopsy
- Patients with bone tumor who underwent/ will undergo only incisional biopsy
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 |
|---|---|---|
| incisional or core-needle biopsy for tumor diagnosisincisional or core-needle biopsy for tumor diagnosis | Procedure or surgery | – |
Primary outcome
compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient.
Time frame: through study completion, an average of 3 year
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 8 Aug 2025.
- Background: PubMed 20512437Kasraeian S, Allison DC, Ahlmann ER, Fedenko AN, Menendez LR. A comparison of fine-needle aspiration, core biopsy, and surgical biopsy in the diagnosis of extremity soft tissue masses. Clin Orthop Relat Res. 2010 Nov;468(11):2992-3002. doi: 10.1007/s11999-010-1401-x.
- Background: PubMed 16788939Mitsuyoshi G, Naito N, Kawai A, Kunisada T, Yoshida A, Yanai H, Dendo S, Yoshino T, Kanazawa S, Ozaki T. Accurate diagnosis of musculoskeletal lesions by core needle biopsy. J Surg Oncol. 2006 Jul 1;94(1):21-7. doi: 10.1002/jso.20504.
- Background: PubMed 23844403Errani C, Traina F, Perna F, Calamelli C, Faldini C. Current concepts in the biopsy of musculoskeletal tumors. ScientificWorldJournal. 2013 Jun 5;2013:538152. doi: 10.1155/2013/538152. Print 2013.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Bone Tumor, run by Istituto Ortopedico Rizzoli at 1 site 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the agreement between core needle biopsy and incisional biopsy, based on Cohen's kappa coefficient. (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07113301, which also lists 3 linked publications.
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 8 Aug 2025.