Banca Di Materiale Biologico Per Lo Studio Di Patologie Che Interessano L'apparato Muscolo-scheletrico (BioBanca)

February 13, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Recruiting
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)
        • Contact:
        • Contact:
          • Giuseppe Banfi, MD
      • Milano, Italy
        • Recruiting
        • Istituto Clinico San Siro (satellite center)
        • Contact:
          • Ileana Albani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giuseppe Banfi, IRCCS Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BioBanca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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