Bone MetastasisNCT06806462
Biomolecular Markers of Bone Metastasis
A study testing Biomolecular profile of bone metastases in people with Bone Metastasis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- Biomolecular profile of bone metastases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2024to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age >= 18 years
- Patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases
- Patients who knowingly express willingness to participate in the study after signing the written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Andrea Sambri, MD, 0512142680, andrea.sambri@aosp.bo.it
About this study
The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis.
The main question it aims to answer is:
Is it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?
Read the detailed description
Metastasization is a process that involves molecular change: potentially colonizable healthy tissues, particularly bone marrow, may "respond" to the production of factors released by the primary tumor, changing some of their funcional molecular characteristics in order to facilitate colonization by circulating tumor cells.
This study aims to describe the biomolecular profile of bone metastases. For this purpose, as per normal clinical practice, patients with carcinomas and who have developed bone metastases will undergo sampling of the metastases and primary tumors.
The activities will have multidisciplinary management. The study will include patients with carcinoma with bone metastases for whom the collection of biological material from the primary lesion and/or bone metastasis is an integral part of the diagnostic-therapeutic procedure or patients for whom, by clinical practice, a biopsy collection is performed because:
- histologic evaluation of the primary or metastatic lesion has been requested;
- a pathologic fracture to be treated surgically occurs;
- prophylactic orthopedic stabilization is required.
These samples will later be analyzed from a molecular point of view in order to identify a biomolecular profile that can help in defining profiles predisposing to bone metastasis and profiles predisposing to pathological fracture risk.
Unsupervised analysis of the emerged transcriptomes will be conducted:
- regardless of tumor histotype (in order to highlight any common facilitating factors for bone metastasis and osteolytic activity),
- by histotype,
- by type of metastasis (osteolytic vs osteosclerotic).
To eliminate analysis error and bias, analyses will be conducted on fresh samples from needle biopsy or intraoperative sampling.
Emerging evidence on transcriptomic analysis will be validated with protein analysis methods and compared with evidence alreadỳ available in the literature.
The analysis being conducted for this study does not influence clinical practice, and all procedures are part of normal clinical practice in the management of patients with bone metastases from carcinoma.
- Conditions
- Bone Metastasis
- Being tested
- Biomolecular profile of bone metastases
- Keywords
- bone, metastasis, biomolecular profile
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomolecular profile of bone metastasesGenetic
Describe the biomolecular profile of bone metastases
| Study group | Role | What they receive |
|---|---|---|
| Bone metastasis | Other | Patients with breast or lung or renal or gastroenteric tract or prostate carcinomas with bone metastases Receives: Genetic: Biomolecular profile of bone metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone metastasis profiling
Characterizing the biomolecular profile of bone metastasis to define the predisposing profiles of bone metastasis.
Transcriptional profile of
- RANK/RANKL
- OPG
- PTHLH
- IL-1/6/7/8/11,
- TNF-alfa
Measured: up to 100 weeks
Fracture pathological profiling
Characterizing the biomolecular profile of bone metastasis to define the predisposing risk profiles of fracture pathological. Fracture event yes/no and association with primary outcomes.
Measured: up to 100 weeks
Secondary outcomes (3)
Comparison between the biomolecular profile of the mestastases and the primary tumor
Trascriptional profile of:
- RANK/RANKL,
- OPG
- PTHLH
- IL-1/6/7/8/11
- TNF-alfa
Measured: up to 100 weeks
Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases
Trascriptional profile of:
- RANK/RANKL,
- OPG
- PTHLH
- IL-1/6/7/8/11
- TNF-alfa
Measured: up to 100 weeks
Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture
Dosage of PTHrp
Measured: Every 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start17 Sep 2024
- Primary completion17 Jun 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Sambri, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806462
- Sponsor's protocol ID
- META_BONE
- Other IDs
- RC-2024-2790611
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomolecular Markers of Bone Metastasis
- ClinicalTrials.gov ID
- NCT06806462
- Acronym / sponsor ID
- META_BONE
- Conditions
- Bone Metastasis
- Keywords
- bone, metastasis, biomolecular profile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 17 Jun 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 4 Feb 2025 (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.
The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis.
The main question it aims to answer is:
Is it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?
Detailed description
Metastasization is a process that involves molecular change: potentially colonizable healthy tissues, particularly bone marrow, may "respond" to the production of factors released by the primary tumor, changing some of their funcional molecular characteristics in order to facilitate colonization by circulating tumor cells.
This study aims to describe the biomolecular profile of bone metastases. For this purpose, as per normal clinical practice, patients with carcinomas and who have developed bone metastases will undergo sampling of the metastases and primary tumors.
The activities will have multidisciplinary management. The study will include patients with carcinoma with bone metastases for whom the collection of biological material from the primary lesion and/or bone metastasis is an integral part of the diagnostic-therapeutic procedure or patients for whom, by clinical practice, a biopsy collection is performed because:
- histologic evaluation of the primary or metastatic lesion has been requested;
- a pathologic fracture to be treated surgically occurs;
- prophylactic orthopedic stabilization is required.
These samples will later be analyzed from a molecular point of view in order to identify a biomolecular profile that can help in defining profiles predisposing to bone metastasis and profiles predisposing to pathological fracture risk.
Unsupervised analysis of the emerged transcriptomes will be conducted:
- regardless of tumor histotype (in order to highlight any common facilitating factors for bone metastasis and osteolytic activity),
- by histotype,
- by type of metastasis (osteolytic vs osteosclerotic).
To eliminate analysis error and bias, analyses will be conducted on fresh samples from needle biopsy or intraoperative sampling.
Emerging evidence on transcriptomic analysis will be validated with protein analysis methods and compared with evidence alreadỳ available in the literature.
The analysis being conducted for this study does not influence clinical practice, and all procedures are part of normal clinical practice in the management of patients with bone metastases from carcinoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone metastasis | Other | Genetic: Biomolecular profile of bone metastasesPatients with breast or lung or renal or gastroenteric tract or prostate carcinomas with bone metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- Patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases
- Patients who knowingly express willingness to participate in the study after signing the written informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Biomolecular profile of bone metastasesDescribe the biomolecular profile of bone metastases | Genetic | Bone metastasis |
Primary outcome
Bone metastasis profiling
Time frame: up to 100 weeks
Characterizing the biomolecular profile of bone metastasis to define the predisposing profiles of bone metastasis. Transcriptional profile of * RANK/RANKL * OPG * PTHLH * IL-1/6/7/8/11, * TNF-alfa
Fracture pathological profiling
Time frame: up to 100 weeks
Characterizing the biomolecular profile of bone metastasis to define the predisposing risk profiles of fracture pathological. Fracture event yes/no and association with primary outcomes.
3 secondary outcomes
Comparison between the biomolecular profile of the mestastases and the primary tumor
Time frame: up to 100 weeks
Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases
Time frame: up to 100 weeks
Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture
Time frame: Every 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Related trials for Bone Metastasis
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
Neoplasm Metastasis / Bone and Bones
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
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. This study is not recruiting at the moment.
Andrea Sambri, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomolecular profile of bone metastases in people with Bone Metastasis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Sambri, MD (0512142680, andrea.sambri@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone metastasis profiling (time frame: up to 100 weeks). The study lists 2 primary outcomes in all. 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 4 Feb 2025.