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Biomolecular Markers of Bone Metastasis

ConditionBone Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Biomolecular profile of bone metastases

    Genetic

    Describe the biomolecular profile of bone metastases

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Bone metastasisOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 100 weeks
2

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.

Time frame
up to 100 weeks

Secondary outcomes

1

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

Time frame
up to 100 weeks
2

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

Time frame
up to 100 weeks
3

Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture

Dosage of PTHrp

Time frame
Every 3-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Source ClinicalTrials.gov
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