Evaluation of Prognostic Factors: From Breast Cancer to Bone Metastases
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 11/14/2019 |
| Estimated Enrollment Submitted: | 11/14/2019 |
| First Posted: | 11/18/2019 |
| Last Update Submitted: | 02/27/2020 |
| Last Update Posted: | 03/01/2020 |
| Actual Study Start Date: | 01/12/2020 |
| Estimated Primary Completion Date: | 11/11/2022 |
| Estimated Study Completion Date: | 11/11/2024 |
Condition or disease
Intervention/treatment
Other: Bone metastasis
Other: Breast cancer metastatic to bone
Phase
Arm Groups
| Arm | 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). | Other: Breast cancer metastatic to bone Patients will be assisted in the recovery of samples (slides) related to surgery on primary tumor (breast cancer responsible for metastatic disease). |
| 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 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. SENP1 expression [6 months]
Secondary Outcome Measures
1. Identification of new predictive molecular markers of breast cancer progression towards an aggressive metastatic state. [18 months]
