Parosteal OsTeosarcoma: a Single Istitution Experience
Conditions: Parosteal Osteosarcoma
Sponsor: Istituto Ortopedico Rizzoli

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“Parosteal OsTeosarcoma: a single institution experience” 
 
Study code POsT 
Sponsor’s Name and 
Address: 
Istituto Ortopedico Rizzoli 
Via di Barbiano 1/10 
40136 Bologna 
Italy 
Study 
Number/Version/Date: 
Vers 1.0  
01 Sep 2018 
Coordinating Center: IRCCS Istituto Ortopedico Rizzoli 
Pathology Unit 
Via Pupilli 1 
40136 Bologna, Italy 
Coordinating 
Investigator and 
address: 
Alberto Righi MD 
Phone: 051-6366.665 
Email: alberto.righi@ior.it 
Scientific/Medical study 
responsible and 
developer 
Alberto Righi MD 
 
Methodology: Retrospective study 
(Single insitution case series review of clinical data) 
Type: Academic 
 
Founding: None 
 
Principal Investigator 
Signature 
I confirm that I’ve read this protocol and I accept to run the study 
in compliance with what is stated in the protocol and with the 
ICh-GCP and all applicable law 
 
Alberto Righi MD 
 
Firma 
 
_________________________ 
 
 
 

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TABLE of CONTENTS 
Background 
 
 
 
 
 
 
 
 
 
pg. 3 
Objective of the study 
 
 
 
 
 
 
 
pg.  3 
Study design   
 
 
 
 
 
 
 
 
pg  3 
Population     
 
 
 
 
 
 
 
 
pg.  3 
Material and Methods   
 
 
 
 
 
 
 
pg.  4 
Statistics 
 
   
 
 
 
 
 
 
 
pg.  4 
Enrolment procedure   
 
 
 
 
 
 
 
pg.  4 
Data Collection            
  
 
 
 
 
 
 
pg.  4 
Informed Consent   
 
  
 
 
 
 
 
 
pg.  5 
Ethic and quality assurance   
 
 
 
 
 
 
pg.  5 
Confidentiality                                                                                       
 
 
pg.  6 
Publication of results                                                        
 
 
             pg.  6 
Sponsor Role and Responsibility                                                                                   pg.  6 
References 
                                                                                       
 
 
pg.  7 
 
 

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BACKGROUND 
Parosteal osteosarcoma is a low-grade, malignant bone tumor arising usually on the metaphyseal 
surface of a long bone. It accounts for about 4% of all osteosarcomas and although rare, it is the 
most common type of osteosarcoma of the surface of bone (1). Around 15-25% of cases reported 
in literature showed high-grade spindle cell areas, indicating progression to high-grade sarcoma 
(dedifferentiation) that may resemble conventional osteosarcoma or undifferentiated spindle or 
pleomorphic sarcoma (2-5). This progression (dedifferentiation) may be seen at the time of the 
first diagnosis or, more often, at the time of recurrence. The medullary involvement of the tumor 
evaluated on CT and MRI and confirmed on histological specimen is another important feature of 
parosteal osteosarcoma that has been described in a variable percentage of cases reported in 
literature (range, 28-48% of series published) (2-5). The presence of the medullary involvement 
could change the surgical treatment, even if it does not seem to have an impact on survival and on 
local recurrence or metastases, at difference to the presence of progression (dedifferentiation) 
areas and of inadequate surgical margins that are the most important prognostic factors in 
parosteal osteosarcoma reported in literature (1-5). This data should be verified in a wide series of 
parosteal osteosarcoma with an adequate follow-up, because the case series but two, reported in 
literature, are limited in terms of number of cases and of time of follow-up (4,5). 
OBJECTIVE OF THE STUDY  
The aim of the present study is to review all the cases with a diagnosis of primary parosteal 
osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively. 
The study will exam all the clinical, radiological, and histological features of this tumor with regard 
importance of medullary involvement, the types of treatment, the status of surgical margins, the 
presence of progression (dedifferentiation) areas and the relationship of these factors to 
individual outcome.  
 
STUDY DESIGN 
This is single institution cases series review of histological and clinical data 
 
POPULATION 
Inclusion criteria 
1) Male and female patients treated at Rizzoli Institute from 01 Jan 1900  to 31 Jul 2018 
2) Diagnosis of parosteal osteosarcoma 

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3) Written informed consent prior to any study-specific analysis and/or data collection  
According to the Italian “Autorizzazione generale n. 9/2016 al trattamento dei dati personali 
effettuato per scopi di ricerca scientifica” of the Privacy Tutor (and the corresponding regulation in 
the other participating countries) the informed consent is not required to be obtained by the 
deceased subjects, as long as all the other enrolment criteria are met and the study has been 
approved by the Ethic Committee (refers to INFORMED CONSENT section) 
 
Exclusion criteria 
1) Patients with histological diagnosis different from parosteal osteosarcoma  
 
MATERIAL AND METHODS 
We will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis 
of parosteal osteosarcoma from 01Jan1900 to 31Jul2018.  
We aspect to find approximately 220 cases.  
We will review all the medical records, radiological imaging, and histological data of these cases.  
 
STATISTICS 
To the case series will be applied a descriptive statistic. 
 
ENROLLMENT PROCEDURE 
Patients considered eligible will be included in the study, after providing a written informed 
consent.  
Since we will include cases of several decades ago, and due to the high incidence of mortality of 
the disease under investigation, it would be possible that some eligible subjects will be deceased. 
 
DATA COLLECTION 
Clinical data will be retrieved by patient charts. 
A protocol-specific CRF reporting the results of the review will be provided. 
A CRF is required and should be completed for each included subject. 
 
 
 

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ETHICS AND QUALITY ASSURANCE 
The clinical trial protocol and its documents will be sent before initiating the study to the 
competent Authorities and Ethics Committees of each participating country for its approval. 
The responsible investigator will ensure that this study is conducted in agreement with either the 
most updated Declaration of Helsinki and all the international and local  laws that apply to clinical 
trials and to patient protection.  
The protocol has been written, and the study will be conducted according to the principles of the 
ICH Harmonized Tripartite Guideline for Good Clinical Practice  
(ref: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf).  
 
INFORMED CONSENT 
All patients will be informed, by the investigator, of the aims of the study, the possible risks and 
benefits that will derive from the study participation. * 
The Investigator must clearly inform that the patient is free to refuse participation in the study and 
that can withdraw consent at any time and for any reason.  
They will be informed as to the strict confidentiality of their patient data, but that their medical 
records may be reviewed for trial purposes by authorized individuals other than their treating 
physician.  
The informed consent procedure must conform to the ICH guidelines on Good Clinical Practice. 
This implies that "the written informed consent form should be signed and personally dated by the 
patient or by the patient's legally acceptable representative".   
The Investigator must also sign the Informed Consent form, and will keep the original at the site 
and a copy of the original must be handed to the patient.  
The competent ethics committee for each Institution participating to the study must validate local 
informed consent documents before the study can be opened. It will be emphasized that the 
participation is voluntary and that the patient is allowed to refuse further participation in the 
study whenever he/she wants. This will not prejudice the patient's subsequent care.  
Due to the high incidence of mortality of the disease under investigation, it would be possible that 
some potential eligible subjects will be deceased.  
In order to allow and promote the increase in the knowledge of this rare disease that could be 
beneficial for other patient that are or will be affected, according to the Italian “Autorizzazione 
generale n. 9/2016 al trattamento dei dati personali effettuato per scopi di ricerca scientifica” of 

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the Privacy Tutor and the corresponding regulation in the other participating country, as well as 
the EU General Data Protection Regulation 679/2016 (that will be applicable from 25 May 2018), 
the informed consent is not required to be obtained by the deceased subjects according the 
aforementioned laws/dispositions. 
 
CONFIDENTIALITY 
In order to ensure confidentiality of clinical trial data as disposed the national and European 
applicable regulation, data will be only accessible for the trial Sponsor and its designees, for 
monitoring/auditing procedures, the Investigator and collaborators, the Ethics Committee of each 
corresponding site and the Health Authority. 
Investigator and the Institution will allow access to data and source documentation for 
monitoring, auditing, Ethic Committee revision and inspections of Health Authority, but 
maintaining at all times subject personal data confidentiality as specified in the “Directive 
95/46/EC of the European Parliament and of the Council of 24 October 1995”.  
 The Investigator must guarantee that patient anonymity is kept at all times and their identity 
must be protected from unauthorized persons and institutions.  
All patients included in the study will be identified with a numeric code, so that no identifiable 
personal data will be collected  (pseudo anonymization) 
The Investigator must have and conserve a patients’ inclusion registry where it figures the 
personal data of the patient: name, surname, address and corresponding identification code into 
the study, this register will be kept on the Investigator File. 
 
PUBBLICATION OF RESULTS  
The results from this study will be published or shown at scientific conferences.  
The final publication of the study results will be written by the Principal Investigator. 
 
SPONSOR ROLE AND RESPONSIBILITY 
The sponsor is the sole owner of the data and is responsible of all the clinical trial activities from 
study design, development, data collection, management, analysis, interpretation of data, writing 
and the decision to submit the report for publication written by the Principal Investigator,  
 
 

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REFERENCES 
[1] Lazar A, Mertens F. Parosteal osteosarcoma. In Fletcher CDM, Bridge JA, Hogendoorn CWH, 
Mertens F. WHO Classification of Tumours of Soft Tissue and Bone, 4th edn. Lyon: IARC Press, 
2013, 292-293. 
[2] Han I, Oh JH, Na YG, Moon KC, Kim HS. Clinical outcome of parosteal osteosarcoma. J Surg 
Oncol. 2008 Feb 1;97(2):146-9. 
[3] Bertoni F, Bacchini P, Staals EL, Davidovitz P. Dedifferentiated parosteal osteosarcoma: the 
experience of the Rizzoli Institute. Cancer. 2005 Jun 1;103(11):2373-82. 
 [4] Okada K, Frassica FJ,Sim FH,Beabout JW, Bond JR,Unni KK (1994) Parosteal osteosarcoma. A 
clinicopathological study. J Bone Joint Surg Am 76: 366–378. 
[5] Laitinen M, Parry M, Albergo JI, Jeys L, Abudu A, Carter S, Sumathi V, Grimer R. The prognostic 
and therapeutic factors which influence the oncological outcome of parosteal osteosarcoma. Bone 
Joint J. 2015 Dec;97-B(12):1698-703.