Evaluation of Prognostic Factors: From Breast Cancer to Bone Metastases

NCT04167605 | Recruiting

• 1 other identifier: BC-BOMET
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bone metastases represent a frequent complication of some solid tumours, particularly prostate, breast and lung carcinomas. Bone metastases can cause pain and give rise to the so-called "Skeletal-related Events" (SRE) such as pathological fractures and nerve compression. Despite advances in cancer treatment in general, treatment options for bone metastases remain inadequate and generally palliative. It is therefore necessary to identify patients at "high risk" of developing metastases at an early stage of neoplastic disease in order to counteract it. Therefore, the identification of changes in the expression of proteins that could be variously involved in the progression of breast cancer is of primary importance since they could act as prognostic factors and therefore address the therapeutic strategy. The aim of the investigators is to clarify the role of de-regulation of post-translational events (such as SUMOylation) in the progression of breast cancer.

Conditions

Breast Cancer Metastatic; Bone Metastases

Keywords

Breast cancer; Bone metastases; SENP1

Outcome Measures

Primary Outcomes (1)

• SENP1 expression

  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 Outcomes (1)

• Identification of new predictive molecular markers of breast cancer progression towards an aggressive metastatic state.

  18 months

Study Arms (2)

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).

Other: Breast cancer metastatic to bone

Bone metastasis

No direct intervention(s) will be administer to the patients. Waste material will be analysed for the expression of specific proteins

Other: Bone metastasis

Interventions

Bone metastasis OTHER

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.

Bone metastasis

Breast cancer metastatic to bone OTHER

Patients will be assisted in the recovery of samples (slides) related to surgery on primary tumor (breast cancer responsible for metastatic disease).

Breast cancer metastatic to bone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of 30 subjects who underwent surgery for bone metastases from breast cancer disease. Within the waste material collected during surgery intervention, it is expected to have 24 samples with an adequate content of metastatic tissue. For 12 of these patients it will be possible to retrieve the sample of the primary breast cancer, and then insert it into the study design. The control group will consist of 12 breast cancer samples that have not shown metastatic development after long follow up and will instead be found in commerce.

You may qualify if:

• 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

You may not qualify if:

• \- Retraction of written consent

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 30918918 BACKGROUND

• 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.

  PMID: 19008217 BACKGROUND

• 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.

  PMID: 27573572 BACKGROUND

• 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.

  PMID: 25759175 BACKGROUND

• 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.

  PMID: 19524509 BACKGROUND

• 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.

  PMID: 19524504 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological waste material derived from patients undergoing excisional surgery and bone consolidation due to osteolytic bone metastases from breast cancer.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bone metastasis-targeting peptidomimetic-11

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Paola Maroni, PhD

CONTACT

+39 026621; paola.maroni@grupposandonato.it

Elena Cittera, MSc

CONTACT

+39 026621; elena.cittera@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: January 13, 2020
• Primary Completion: September 12, 2024
• Study Completion: November 12, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)