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CompletedNCT06714773Updated Dec 4, 2024

Grade 2 Chondrosarcoma Treated by Intralesional Curettage: Follow-up vs Resection

An observational study in Chondrosarcoma, Grade 2, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
62
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chondrosarcoma, Grade 2

Keywords

  • intralesional curettage
03

In context

Chondrosarcoma

99 studies on the registry are indexed under Chondrosarcoma; 20 are open to participants now.

This study's enrollment of 62 is below the median of 72 across 17 observational studies indexed under Chondrosarcoma.

Browse Chondrosarcoma studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
62 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Tumor recurrence(%)

    It will be measured by: X-Rays, CT, MRI, PET CT scan

    Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

  2. distant metastasis (%)

    It will be measured by: CT scan of the lungs, PET CT scan

    Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

07

Study locations

1 site
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, 40138, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06714773
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Jan 20, 2024
Primary completion
Jul 20, 2024
Completion
Aug 1, 2024
Last update
Dec 4, 2024

Study contacts

Andrea Sambri, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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