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Molecularly redefining small bowel adenocarcinoma to accelerate precision patient care - protocol of a multicenter
Rasmus Haunstrup Døssing1, Julia Johanna Almer Broman2, Colm J O'Rourke3
1Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Borgmester Ib Juuls Vej 1, Herlev, 2730, Denmark. rasmus.haunstrup.doessing@regionh.dk.
Background:
Small Bowel Adenocarcinoma (SBA) is a rare gastrointestinal cancer with a limited understanding of the molecular pathology. This study aims to bridge the knowledge gap, providing a robust molecular foundation for SBA and addressing the clinical challenges inherent in treating this orphan disease. The study proposes to redefine the clinical management for SBA patients through advanced molecular profiling techniques to improve potential precision medicine.
Methods/Design:
This National multicenter, observational cohort study combines retrospective and prospective analyses across Danish University Hospitals. The study enrolls patients diagnosed with SBA, retrospectively from 2009 and prospectively from 2022 onwards. Molecular profiling, including DNA, RNA, and T-cell receptor sequencing, will be conducted on SBA tissue samples. The primary outcome is to categorize SBA into consensus molecular-guided subgroups. Secondary outcomes include correlating these subgroups with clinical features, treatment responses, and patient outcomes. Machine learning algorithms will be employed for bioinformatic analyses to interpret molecular data. Ethical approval has been obtained, and patient consent will be secured for the retrospective study component.
Discussion:
The molecular and clinical characterization of SBA is expected to add novel insights into the heterogeneity of this rare disease. By identifying molecular subgroups, the research could enable the development of personalized treatment strategies, a paradigm shift within SBA. The study acknowledges the challenges of working with orphan diseases, including limited patient numbers and diverse clinical presentations. However, its findings will have the potential to substantially impact future clinical practices and guide targeted therapies for SBA patients.
Trial Registration:
ClinicalTrials.gov NCT06234306.
Insights
This study investigates the molecular characteristics of Small Bowel Adenocarcinoma (SBA), a rare cancer. Findings aim to define molecular subgroups for personalized treatment strategies and improved patient outcomes in this orphan disease.
Area of Science:
- Oncology
- Genomics
- Precision Medicine
Background:
- Small Bowel Adenocarcinoma (SBA) is a rare gastrointestinal malignancy with poorly understood molecular pathology.
- Addressing the clinical challenges of SBA requires a deeper understanding of its molecular underpinnings.
- This research aims to establish a molecular foundation for SBA to enhance precision medicine approaches.
Purpose of the Study:
- To bridge the knowledge gap in SBA molecular pathology.
- To redefine clinical management through advanced molecular profiling.
- To improve potential precision medicine strategies for SBA patients.
Main Methods:
- A national multicenter, observational cohort study combining retrospective and prospective analyses.
- Molecular profiling of SBA tissue samples using DNA, RNA, and T-cell receptor sequencing.
- Application of machine learning algorithms for bioinformatic analysis of molecular data.
Main Results:
- Categorization of SBA into consensus molecular-guided subgroups.
- Correlation of molecular subgroups with clinical features, treatment responses, and patient outcomes.
- Identification of novel insights into the heterogeneity of SBA.
Conclusions:
- Molecular and clinical characterization of SBA will provide crucial insights into disease heterogeneity.
- Identification of molecular subgroups may enable personalized treatment strategies for SBA.
- Findings have the potential to impact clinical practice and guide targeted therapies for SBA.
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