ChondromaCONDRO1NCT02996747
Low Grade Chondrosarcoma Versus Enchondroma
An observational study of Chondroma and Chondrosarcoma, run by Istituto Ortopedico Rizzoli.
Trial summary
The purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chondroma, Chondrosarcoma
- What is being tested?
- curettage (intralesional surgery)
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chondroma or low grade chondrosarcoma of bone treated in a single Institution
Who may be able to join
- chondroma or low grade chondrosarcoma of long bones
Who cannot join
- chondroma or low grade chondrosarcoma of spine and pelvis
About this study
Official title: Low Grade Chondrosarcoma Versus Enchondroma: Challenges in Diagnosis and Management
The purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).
Read the detailed description
The investigators retrospectively review the records of 65 patients with enchondroma and 37 patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and 2014 in a single Institution.
- Conditions
- Chondroma, Chondrosarcoma
- Being tested
- curettage (intralesional surgery)
- Keywords
- bone tumors, chondroma, chondrosarcoma
- Medical subject headings
- Chondroma, Chondrosarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curettage (intralesional surgery)Procedure or surgery
comparison of two different tumors treated by curettage
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChondromaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costantino Errani, Istituto Ortopedico Rizzoli
- Investigators
- Davide Donati, MD, Study director, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996747
- Sponsor's protocol ID
- 0016890
- Acronym
- CONDRO1
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publish a paper in international medical journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Grade Chondrosarcoma Versus Enchondroma: Challenges in Diagnosis and Management
- ClinicalTrials.gov ID
- NCT02996747
- Acronym / sponsor ID
- CONDRO1 / 0016890
- Conditions
- Chondroma, Chondrosarcoma
- Keywords
- bone tumors, chondroma, chondrosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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 purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).
Detailed description
The investigators retrospectively review the records of 65 patients with enchondroma and 37 patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and 2014 in a single Institution.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chondroma or low grade chondrosarcoma of bone treated in a single Institution
Key inclusion criteria (1 listed)
- chondroma or low grade chondrosarcoma of long bones
Key exclusion criteria (1 listed)
- chondroma or low grade chondrosarcoma of spine and pelvis
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 |
|---|---|---|
| curettage (intralesional surgery)comparison of two different tumors treated by curettage | Procedure or surgery | – |
Primary outcome
Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery)
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Individual participant dataSharing planned: Yes. publish a paper in international medical journal
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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.
Davide Donati, MD study director
Istituto Ortopedico Rizzoli
Questions about this trial
What is this clinical trial studying?
An observational study of Chondroma and Chondrosarcoma, run by Istituto Ortopedico Rizzoli.
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 1 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: finished, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery) (time frame: 36 months). 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 22 Dec 2016.