Tissue BankingBioBancaNCT03208062
Banca di Materiale Biologico Per lo Studio di Patologie Che Interessano l'Apparato Muscolo-scheletrico
An observational study of Tissue Banking, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Banking
- What is being tested?
- collection of waste materials
- How many people
- 1,500 participants
- Where
- 2 sitesItaly
- Study dates
- 31 May 2017to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target group corresponds to the patients admitted to our Institute who are candidates for the following surgical or biopsy procedures: * patients with osteoarthritis of the hip or knee and rehabilitated in the institute * patients with primary and secondary tumors of the skeleton * patients undergoing prosthetic examination as a result of plant infection The population will include adult subjects. Patients will be considered eligible for enrollment in the project if they can provide informed written consent.
Who may be able to join
- 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
Who cannot join
- Participants aged <18 years
- Participants unable to release the Informed Consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)
Milan, 20157
Sara Zacchetti, +390283502227, sara.zacchetti@grupposandonato.it
Giuseppe Banfi, MD
- Recruiting
Istituto Clinico San Siro (satellite center)
Milan
Ileana Albani
About this study
Official title: Costituzione di Una Banca di Materiale Biologico da Paziente (Biobanca) Per lo Studio di Patologie Che Interessano l'Apparato Muscolo-scheletrico
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.
Read the detailed 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.
- Conditions
- Tissue Banking
- Being tested
- collection of waste materials
- Keywords
- Biobank, Waste material, Orthopaedic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of waste materialsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | The target group corresponds to the patients admitted to our Institute who are candidates for the following surgical or biopsy procedures and collection of waste materials:
* patients with osteoarthritis of the hip or knee and rehabilitated in the institute
* patients with primary and secondary tumors of the skeleton
* patients undergoing prosthetic examination as a result of plant infection The population will include adult subjects(>18 years included). Patients will be considered eligible for enrollment in the project if they can provide informed written consent. Receives: Other: collection of waste materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start31 May 2017
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue BankingStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Banfi, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208062
- Sponsor's protocol ID
- BioBanca
- Acronym
- BioBanca
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costituzione di Una Banca di Materiale Biologico da Paziente (Biobanca) Per lo Studio di Patologie Che Interessano l'Apparato Muscolo-scheletrico
- ClinicalTrials.gov ID
- NCT03208062
- Acronym / sponsor ID
- BioBanca / BioBanca
- Conditions
- Tissue Banking
- Keywords
- Biobank, Waste material, Orthopaedic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: collection of waste materialsThe target group corresponds to the patients admitted to our Institute who are candidates for the following surgical or biopsy procedures and collection of waste materials: * patients with osteoarthritis of the hip or knee and rehabilitated in the institute * patients with primary and secondary tumors of the skeleton * patients undergoing prosthetic examination as a result of plant infection The population will include adult subjects(>18 years included). Patients will be considered eligible for enrollment in the project if they can provide informed written consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target group corresponds to the patients admitted to our Institute who are candidates for the following surgical or biopsy procedures: * patients with osteoarthritis of the hip or knee and rehabilitated in the institute * patients with primary and secondary tumors of the skeleton * patients undergoing prosthetic examination as a result of plant infection The population will include adult subjects. Patients will be considered eligible for enrollment in the project if they can provide informed written consent.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participants aged <18 years
- Participants unable to release the Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of waste materialsosteoarthritis 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 | Other | Patients |
Primary outcome
BioBanking of waste biological materials
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Banfi principal investigator
IRCCS Istituto Ortopedico Galeazzi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Banking, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Cittera (00390283502224, elena.cittera@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BioBanking of waste biological materials (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.