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

November 28, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months, 6 months, 1 year, 2 years, 5 years, 10 years
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
3 months, 6 months, 1 year, 2 years, 5 years, 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Andrea Sambri, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONDRO2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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