Low Grade Chondrosarcoma Versus Enchondroma | NCT02996747

Studies
Low Grade Chondrosarcoma Versus Enchondroma

NCT02996747

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Dec 22, 2016Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Chondroma
Chondrosarcoma

Interventions

curettage (intralesional surgery)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Dec 15, 2016

First Submission Date that Met QC Criteria

Dec 16, 2016

First Posted Date

Dec 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
curettage (intralesional surgery)	Procedure	comparison of two different tumors treated by curettage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery)		36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chondroma or low grade chondrosarcoma of long bones

Exclusion Criteria:

chondroma or low grade chondrosarcoma of spine and pelvis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with chondroma or low grade chondrosarcoma of bone treated in a single Institution

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Davide Donati, MD	Istituto Ortopedico Rizzoli	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

publish a paper in international medical journal

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002812	Chondroma
D002813	Chondrosarcoma
D001859	Bone Neoplasms

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003475	Curettage

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided