Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Small Bowel Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Small bowel adenocarcinoma is a rare malignancy, and there is limited knowledge about its optimal clinical management and molecular background. The SBAMOL study is an observational biomarker study that aims to identify prognostic and predictive biomarkers. This effort is intended to lay the groundwork for personalized medicine tailored to this specific patient group.
Detailed description
Small bowel adenocarcinoma (SBA), an orphan cancer, has annual diagnoses of 12,070 in the USA and 100 in Denmark. Despite its rarity, patient management should prioritize evidence-based care, but large trials are not feasible, leading to data scarcity and suboptimal care. As a result, SBA is treated like colorectal cancer, yet its prognosis is worse, indicating this parallel approach is insufficient. The grasp on SBAs molecular landscape is limited compared to prevalent cancers. Scant mutational profiling studies, suggest SBA is a heterogeneous disease where subsets resemble other gastrointestinal cancers. This underscores the potential for personalized treatments, including targeted therapies and immunotherapies. Comprehensive molecular characterization, using DNA, RNA, and T-cell receptor characteristics, can provide much-needed strategic direction for patient care and future trials. Capitalizing on this, the investigators propose a comprehensive molecular characterization aiming to develop consensus molecular subtypes that can direct future trials and SBA therapeutic strategies.
The investigators hypothesize that a consensus molecular profiling approach can identify subgroups of SBA with distinct molecular, cellular, and histological characteristics, that will benefit from tailored treatment strategies using chemotherapy, targeted therapy, and immunotherapy.
To explore this hypothesis, the investigators will: (WP1) perform molecular and immunological characterization of tumor tissues from SBA patients (n=200) to establish consensus molecular subtypes of SBA and define their biological attributes; (WP2) ascertain therapeutic avenues tailored to each subtype and devise a molecular algorithm to prospectively categorize individual tumors in real-time, laying the groundwork for molecularly-driven management.
Primary outcome measures
- Molecular characterization of patients with SBA using high-throughput DNA-, mRNA- and T-cell receptor sequencing and targeted protein expression analyses. [Time frame: 5 years]
Secondary outcome measures (3)
- Prognostic and predictive DNA biomarkers in patients with SBA [Time frame: 5 years]
- Prognostic and predictive mRNA biomarkers in patients with SBA [Time frame: 5 years]
- Prognostic t-cell receptor biomarkers in patients with SBA [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
Patients with histologically verified small bowel adenocarcinoma Patients older than 18 years
Exclusion criteria
Insufficient material for molecular testing Patients registered in Vævsanvendelsesregistret\&
Vævsanvendelsesregistret; refers to a central Danish registry where patients can opt out of allowing their biological material to be used for purposes other than their own disease management.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Department of Oncology, Aarhus University Hospital — Aarhus N
- Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet — Copenhagen Ø
- Department of Oncology Copenhagen University Hospital - Herlev and Gentofte — Herlev
Publications
- Dossing RH, Broman JJA, O'Rourke CJ, Tabaksblat EM, Andersen JB, Hansen CP, Poulsen TS, Hogdall EVS, Schou JHV, Hogdall D. Molecularly redefining small bowel adenocarcinoma to accelerate precision patient care - protocol of a multicenter observational cohort biomarker study. BMC Cancer. 2025 Jan 7;25(1):22. doi: 10.1186/s12885-024-13369-1. PMID 39773121
Identifiers
NCT: NCT06234306 · 2312342