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an Istitution Experience on Parosteal OsTeosarcoma

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ClinicalTrials.gov Identifier: NCT03768076
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Tracking Information
First Submitted Date November 22, 2018
First Posted Date December 7, 2018
Last Update Posted Date December 14, 2018
Actual Study Start Date November 30, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2018)
retrospective analysis of cases of Parosteal osteosarcoma [ Time Frame: at baseline (Day0) ]
Investigators will exam the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03768076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title an Istitution Experience on Parosteal OsTeosarcoma
Official Title Parosteal OsTeosarcoma: a Single Istitution Experience
Brief Summary single institution cases series review of histological and clinical data
Detailed Description Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population male and female with diagnosis of parosteal osteosarcoma treated at Rizzoli institute from 01 Jan 1900 to 31 Jul 2018
Condition Parosteal Osteosarcoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 5, 2018)
220
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018
  • Diagnosis of parosteal osteosarcoma
  • Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

• Patients with histological diagnosis different from parosteal osteosarcoma

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Alberto Righi +390516366 ext 655 alberto.righi@ior.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03768076
Other Study ID Numbers POsT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No Individual Patient Data sharing plan has been implemented
Responsible Party Istituto Ortopedico Rizzoli
Study Sponsor Istituto Ortopedico Rizzoli
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Ortopedico Rizzoli
Verification Date November 2018