- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167605
Evaluation of Prognostic Factors: From Breast Cancer to Bone Metastases (BC-BOMET)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The most serious aspect of neoplastic disease is the spread of cancer cells to secondary sites, often distant from the primary site of growth. Bone is a breeding ground for many types of cancer, especially those derived from breast, prostate and lung. Despite the enormous progress in diagnosis and therapeutic strategies, bone metastases still have a profound impact on quality of life and survival, being often responsible for the outcome of the disease. To improve the outcome of patients with poor prognosis, a deep knowledge of the mechanisms underlying dissemination, colonization and progression of cancer cells in the bone is necessary.
The investigators therefore intend to clarify some pathogenic mechanisms involved in the growth of bone metastases, and to uncover predictive signs that underlie the spread of breast cancer cells to bone.
Primary aim of the investigators is to deepen the role of the de-regulation of post-translational events, such as Small Ubiquitin-like Modifier- (SUMO) SUMO-ylation in the progression of breast cancer. The expression of SENP1 (a member of the SUMO-specific protease family) in bone metastatic and non-metastatic mammary carcinomas will be evaluated. The evaluation of the expression of SENP1 in bone metastases will be finalised to define a possible use as a therapeutic target. SENP1 could be a potential prognostic indicator of the neoplastic progression of breast cancer and a potential therapeutic target, but data on its participation in the process of metastasis to bone are still scarce. Moreover, the investigators try to deepen the knowledge of the interaction between tumour cells and bone microenvironment and the role of immunosurveillance as an important part of the immune response against to neoplastic cells. Finally, the investigators will analyze the role of autophagy and apoptosis in the dissemination and growth of metastases due to the capacity of autophagy to provide energy, nutrients and resistance to anoikis, and to promote the dissemination of cancer cells and metastatic growth.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paola Maroni, PhD
- Phone Number: 4759 +39 026621
- Email: paola.maroni@grupposandonato.it
Study Contact Backup
- Name: Elena Cittera, MSc
- Phone Number: 4057 +39 026621
- Email: elena.cittera@grupposandonato.it
Study Locations
-
-
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Milan, Italy, 20161
- Recruiting
- IRCCS Istituto Ortopedico Galeazzi
-
Contact:
- Paola Maroni, PhD
- Phone Number: 4759 +39 026621
- Email: paola.maroni@grupposandonato.it
-
Principal Investigator:
- Paola Maroni, PhD
-
Contact:
- Elena Cittera, MSc
- Phone Number: 4057 +39 026621
- Email: elena.cittera@grupposandonato.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult women (≥ 18 years) candidates for excisional surgery and bone consolidation due to osteolytic bone metastases from breast cancer.
- Female
- Ability to understand the experimental study and willingness to sign the written consent
Exclusion Criteria:
- Retraction of written consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Breast cancer metastatic to bone
No direct intervention(s) will be administer to the patients.
We will use the sample (slides) recovered from the surgery on primary tumor (breast cancer responsible for metastatic disease).
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Patients will be assisted in the recovery of samples (slides) related to surgery on primary tumor (breast cancer responsible for metastatic disease).
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Bone metastasis
No direct intervention(s) will be administer to the patients.
Waste material will be analysed for the expression of specific proteins
|
Collection of waste tissue samples during surgery and immediate immersion of the same in 10% Neutral buffered formalin.
The samples will be send to the laboratory where they will be processed (decalcification, inclusion in paraffin, sectioning etc.) for subsequent analyzes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SENP1 expression
Time Frame: 6 months
|
The expression of SENP1 in bone metastatic mammary carcinomas will be studied.
The evaluation of the expression of SENP1 in bone metastases will be finalized to define a possible use as a therapeutic target.
The expression of SENP1 in bone metastatic breast carcinoma samples will be compared with the expression of SENP1 in non-metastatic breast cancer (commercial source).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of new predictive molecular markers of breast cancer progression towards an aggressive metastatic state.
Time Frame: 18 months
|
Analysis of the expression of proteins involved in the interaction between tumour cells and bone microenvironment, in the immunosurveillance and in the autophagic process in sample of mammary carcinomas that gave rise to bone metastases and in sample of breast cancer without history of bone metastasis.
|
18 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sowder ME, Johnson RW. Bone as a Preferential Site for Metastasis. JBMR Plus. 2019 Jan 15;3(3):e10126. doi: 10.1002/jbm4.10126. eCollection 2019 Mar.
- Yeh ET. SUMOylation and De-SUMOylation: wrestling with life's processes. J Biol Chem. 2009 Mar 27;284(13):8223-7. doi: 10.1074/jbc.R800050200. Epub 2008 Nov 13.
- Wang Z, Jin J, Zhang J, Wang L, Cao J. Depletion of SENP1 suppresses the proliferation and invasion of triple-negative breast cancer cells. Oncol Rep. 2016 Oct;36(4):2071-8. doi: 10.3892/or.2016.5036. Epub 2016 Aug 24.
- Feng Y, Yao Z, Klionsky DJ. How to control self-digestion: transcriptional, post-transcriptional, and post-translational regulation of autophagy. Trends Cell Biol. 2015 Jun;25(6):354-63. doi: 10.1016/j.tcb.2015.02.002. Epub 2015 Mar 8.
- Mathew R, Karp CM, Beaudoin B, Vuong N, Chen G, Chen HY, Bray K, Reddy A, Bhanot G, Gelinas C, Dipaola RS, Karantza-Wadsworth V, White E. Autophagy suppresses tumorigenesis through elimination of p62. Cell. 2009 Jun 12;137(6):1062-75. doi: 10.1016/j.cell.2009.03.048. Erratum In: Cell. 2011 Apr 15;145(2):322.
- Moscat J, Diaz-Meco MT. p62 at the crossroads of autophagy, apoptosis, and cancer. Cell. 2009 Jun 12;137(6):1001-4. doi: 10.1016/j.cell.2009.05.023.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-BOMET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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