Fibrotic Focus in Breast Cancer
Characterization of Fibrotic Focus as a Prognostic Marker in Breast Cancer
1 other identifier
observational
250
0 countries
N/A
Brief Summary
Despite the ongoing refinement of current breast cancer staging, clinical outcome is still varied among patients of similar stage. Further exploration of novel prognostic factors is of great clinical value. In our earlier findings, we have demonstrated the added value of fibrotic focus (FF) in the current staging. However the precise composition in different components within FF and underlying mechanism involved remain to be determined. In fact, there is unappreciated heterogeneity in FF. All these have limited its application in clinical practice. In this proposal, a systemic evaluation on the FF features in breast cancers will be performed. We aim to further characterize FF at morphological, cellular and molecular levels as well as its collagen characteristics. Given the multiple lines of evidence showing its relationship with immune components, additional attention will be put on its interaction with immune tumor environment. Finally, we plan to develop prognostic model integrating these different FF features for a more accurate risk stratification. Accumulated evidence suggested that the significance of FF in breast cancer prognosis. Moreover, the impact of fibrotic stroma on tumor immune environment may be implicative in immunotherapy. The more complete understanding of FF is pre-requisite for its development as an applicable prognostic marker in breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedOctober 10, 2019
October 1, 2019
3 years
October 8, 2019
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Prognostic value of fibrotic focus
AUC in percentage (%) in prognostic model based on fibrotic focus features
Five years after patients recruitment
Interventions
Immunohistochemical analysis of biomarker in post-surgical sample
Eligibility Criteria
primary care clinic
You may qualify if:
- Patients with diagnosis of breast cancer who underwent surgical excisions with all tumor blocks available
You may not qualify if:
- Patients who received neoadjuvant systemic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior medical officer
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 10, 2019
Study Start
December 1, 2019
Primary Completion
November 30, 2022
Study Completion
November 30, 2023
Last Updated
October 10, 2019
Record last verified: 2019-10