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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03208062
Other study ID # BioBanca
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 31, 2017
Est. completion date May 31, 2027

Study information

Verified date February 2024
Source I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Contact Elena Cittera
Phone 00390283502224
Email elena.cittera@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Musculoskeletal disorders are an heterogeneous group of diseases that represent one of the major causes of disability. Considering the importance of studying these pathologies, it is necessary to develop research lines based on the availability of human biological material from highly clinically relevant patients. The purpose of this project is therefore the establishment of a bank of biological material (biobank) to investigate important aspects related to the pathologies of the musculoskeletal system through subsequent bio-molecular characterization studies.


Description:

Musculoskeletal disorders constitute an heterogeneous group of diseases which represent one of the major causes of disability. These include degenerative, traumatic, genetic, metabolic and primitive and secondary tumor illnesses. Among the pathologies of the musculoskeletal system are extremely widespread and rare. Among the earliest can be illnesses such as osteoarthritis and osteoporosis which, due to their high frequency in the population, have a high impact not only at the personal but also at social level. The study of these pathologies to identify new therapeutic targets is therefore a goal of great strategic importance. In the oncological field, the skeleton is also one of the most common metastatic sites along with lung, brain and liver. Bone metastases have devastating effects on the quality of life of affected patients and result from the activation of extremely complex molecular mechanisms whose comprehension would allow identification of targets for their prevention and treatment, a key goal to date still reached. Unlike secondary bone tumors, primary tumors are a rare group of tumors. As such, research into these types of pathologies has often been limited by the low availability of human samples. Further characterization of these tumors is still necessary to promote proper recognition and improve treatment. Considering the importance of studying these pathologies, it is necessary to establish a biobank of highly valuable biological material that would be the fundamental basis for the subsequent setting up and activation of research projects. The establishment of biobanks has been a fundamental support for the development of many research projects in a wide variety of fields. Currently there isn't a biobank at IRCCS Galeazzi Orthopedic Institute. The purpose of this project is therefore the creation of a biobank to investigate relevant aspects related to musculoskeletal disorders through subsequent bio-molecular characterization studies.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date May 31, 2027
Est. primary completion date May 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients admitted to our Institute - Patients aged =18 years - Patients with osteoarthritis of hip or knee and rehabilitated in the institute - Patients with primary and secondary tumors of the skeleton - Patients undergoing prosthetic surgery following infection of the implant Exclusion Criteria: - Participants aged <18 years - Participants unable to release the Informed Consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
collection of waste materials
osteoarthritis of the hip or knee and rehabilitated in the institute; primary and secondary tumors of the skeleton; prosthetic examination as a result of plant infection

Locations

Country Name City State
Italy IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator) Milan
Italy Istituto Clinico San Siro (satellite center) Milano

Sponsors (1)

Lead Sponsor Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary BioBanking of waste biological materials The aim of the project is to create a biobanch of waste material from patients undergoing prosthetic surgery and hospital rehabilitation and oncologic orthopedic surgery to be used in specific studies aimed at defining the pathophysiological bases and / or new possible criteria Diagnostic / prognosis of locomotor system pathologies and, specifically, osteoarthritis of the hip and knee, primary and secondary bone tumors, infection of hip and knee prostheses requiring plant revision. 5 years
See also
  Status Clinical Trial Phase
Completed NCT00032578 - VA Genetic Tissue Banking N/A