Chondrosarcoma, Grade 2NCT06714773
Grade 2 Chondrosarcoma Treated by Intralesional Curettage: Follow-up vs Resection
An observational study of Chondrosarcoma, Grade 2, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to assess the oncological outcomes in patients diagnosed with grade 2 chondrosarcoma, treated with intralesional curettage, stratified into two cohorts: those subjected to follow up monitoring and those who have undergone subsequent surgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondrosarcoma, Grade 2
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2024to 1 Aug 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients with diagnosis of grade 2 chondrosarcoma of the appendiceal skeleton who underwent intralesional curettage surgery, treated between 01/01/2008 and 31/12/2020.
Who may be able to join
- Patients with a diagnosis of grade 2 chondrosarcoma of the appendiceal skeleton in the definitive specimen;
- Patients treated with intralesional curettage surgery;
- Patients aged >=18 years;
- Patients who were treated between 01/01/2008 and 31/12/2020.
Who cannot join
- Patients diagnosed with grade 1 or 3 chondrosarcoma on the histological diagnosis of the operative specimen.
- Patients undergoing wide resection as the primary treatment.
- Patients with less than 12 months follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to assess the oncological outcomes in patients diagnosed with grade 2 chondrosarcoma, treated with intralesional curettage, stratified into two cohorts: those subjected to follow up monitoring and those who have undergone subsequent surgical intervention.
Read the detailed description
Large resection of the tumor is considered the treatment of choice in patients affected by grade 2 chondrosarcoma. Nonetheless, a preoperative diagnosis of a lower grade lesion (ChS grade 1) is not infrequent, thus making these patients treated with intralesional curettage. Intralesional curettage is a type of surgery in which the pathological component is removed from the affected bone and the resulting bone defects can be filled with bone substitutes or bone cement. Bone cortexes are left in place like a shell.
The results of this study could contribute to find the right therapeutic pathway in patients affected by grade 2 chondrosarcoma treated with intralesional curettage, in particular in patients who underwent further surgery (bone resection) or follow-up. Since outcome data are scarce in the literature, the results of this study could be used to assess the feasibility of a randomized controlled trial with the correct sample size.
It is an explorative, spontaneous, non-profit, retrospective, observational study.
It involves the pseudonymous data collection of all patients matching inclusion criteria. The data recorded in this study are extracted from the medical records of patients who regularly seek care from the medical unit during their routine clinical visits. Following a meticulous collection of patients' baseline data, the two therapeutic options (clinical monitoring or bone resection) in patients affected by grade 2 chondrosarcoma treated with intralesional curettage will be compared.
Data related to demographics, histologic and treatment data will be collected. Oncologic follow-up data will be also collected. In particular, data related to local recurrences, distant metastasis and survival will be evaluated.
- Conditions
- Chondrosarcoma, Grade 2
- Keywords
- intralesional curettage
- Medical subject headings
- Chondrosarcoma, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence(%)
It will be measured by: X-Rays, CT, MRI, PET CT scan
Measured: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
distant metastasis (%)
It will be measured by: CT scan of the lungs, PET CT scan
Measured: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start20 Jan 2024
- Primary completion20 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondrosarcoma, Grade 2Studies 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
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Sambri, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714773
- Sponsor's protocol ID
- CONDRO2
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grade 2 Chondrosarcoma Treated by Intralesional Curettage: Follow-up vs Resection
- ClinicalTrials.gov ID
- NCT06714773
- Acronym / sponsor ID
- CONDRO2
- Conditions
- Chondrosarcoma, Grade 2
- Keywords
- intralesional curettage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 4 Dec 2024 (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 assess the oncological outcomes in patients diagnosed with grade 2 chondrosarcoma, treated with intralesional curettage, stratified into two cohorts: those subjected to follow up monitoring and those who have undergone subsequent surgical intervention.
Detailed description
Large resection of the tumor is considered the treatment of choice in patients affected by grade 2 chondrosarcoma. Nonetheless, a preoperative diagnosis of a lower grade lesion (ChS grade 1) is not infrequent, thus making these patients treated with intralesional curettage. Intralesional curettage is a type of surgery in which the pathological component is removed from the affected bone and the resulting bone defects can be filled with bone substitutes or bone cement. Bone cortexes are left in place like a shell.
The results of this study could contribute to find the right therapeutic pathway in patients affected by grade 2 chondrosarcoma treated with intralesional curettage, in particular in patients who underwent further surgery (bone resection) or follow-up. Since outcome data are scarce in the literature, the results of this study could be used to assess the feasibility of a randomized controlled trial with the correct sample size.
It is an explorative, spontaneous, non-profit, retrospective, observational study.
It involves the pseudonymous data collection of all patients matching inclusion criteria. The data recorded in this study are extracted from the medical records of patients who regularly seek care from the medical unit during their routine clinical visits. Following a meticulous collection of patients' baseline data, the two therapeutic options (clinical monitoring or bone resection) in patients affected by grade 2 chondrosarcoma treated with intralesional curettage will be compared.
Data related to demographics, histologic and treatment data will be collected. Oncologic follow-up data will be also collected. In particular, data related to local recurrences, distant metastasis and survival will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients with diagnosis of grade 2 chondrosarcoma of the appendiceal skeleton who underwent intralesional curettage surgery, treated between 01/01/2008 and 31/12/2020.
Key inclusion criteria (4 listed)
- Patients with a diagnosis of grade 2 chondrosarcoma of the appendiceal skeleton in the definitive specimen;
- Patients treated with intralesional curettage surgery;
- Patients aged >=18 years;
- Patients who were treated between 01/01/2008 and 31/12/2020.
Key exclusion criteria (3 listed)
- Patients diagnosed with grade 1 or 3 chondrosarcoma on the histological diagnosis of the operative specimen.
- Patients undergoing wide resection as the primary treatment.
- Patients with less than 12 months follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor recurrence(%)
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
It will be measured by: X-Rays, CT, MRI, PET CT scan
distant metastasis (%)
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
It will be measured by: CT scan of the lungs, PET CT scan
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 4 Dec 2024.
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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.
Andrea Sambri, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Chondrosarcoma, Grade 2, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 3 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 4 Dec 2024. 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?
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?
Tumor recurrence(%) (time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years). The study lists 2 primary outcomes in all. 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 4 Dec 2024.