Small Bowel AdenocarcinomaSBAMOLNCT06234306
Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care
An observational study of Small Bowel Adenocarcinoma, run by Copenhagen University Hospital at Herlev at 3 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Adenocarcinoma
- How many people
- 500 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Jan 2024to 31 Dec 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with small bowel adenocarcinoma referred to management at participating centers
Who may be able to join
- Patients with histologically verified small bowel adenocarcinoma Patients older than 18 years
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Oncology, Aarhus University Hospital
Aarhus N, Denmark, 8200
Elizaveta M Tabaksblat, MD PhD, 004578450000, eliza.mit.tab@auh.rm.dk
Elizaveta M Tabaksblat, MD PhD
- Recruiting
Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet
Copenhagen Ø, Denmark, 2100
Carsten P Hansen, MD DMSc, 004535453545, carsten.palnaes.hansen@regionh.dk
Carsten P Hansen, MD DMSc
- Recruiting
Department of Oncology Copenhagen University Hospital - Herlev and Gentofte
Herlev, Denmark, 2730
Dan Hogdall, MD PhD, 004538681954, danhog01@regionh.dk
Dan Hogdall, MD PhD
About this study
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.
Read the 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.
- Conditions
- Small Bowel Adenocarcinoma
- Keywords
- Small bowel adenocarcinoma, messenger RNA, DNA, T-cell receptor sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular characterization of patients with SBA using high-throughput DNA-, mRNA- and T-cell receptor sequencing and targeted protein expression analyses.
Due to the scarce knowledge of the biological background of SBA. The primary endpoint of the study is to present a comprehensive descriptive molecular characterisation of patients with SBA.
Measured: 5 years
Secondary outcomes (3)
Prognostic and predictive DNA biomarkers in patients with SBA
DNA aberrations will associated with disease free, progression free and overall survival. Analysis will be performed using the Oncomine comprehensive plus gene panel. Potential aberrations indicative of targeted treatments will be explored and reported.
Measured: 5 years
Prognostic and predictive mRNA biomarkers in patients with SBA
mRNA aberrations will associated with disease free, progression free and overall survival. Analysis will be performed using high-throughput sequencing. Potential aberrations indicative of targeted treatments will be explored and reported.
Measured: 5 years
Prognostic t-cell receptor biomarkers in patients with SBA
T-cell receptor clonality and diversity will associated with disease free, progression free and overall survival. Analysis will be performed using a high-throughput t-cell receptor sequencing.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, University of Copenhagen
- Responsible party
- Principal investigator, Dan Hogdall, Copenhagen University Hospital at Herlev
- Investigators
- Dan Høgdall, MD PhD, Principal investigator, Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234306
- Sponsor's protocol ID
- 2312342
- Acronym
- SBAMOL
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to Danish ethical regulations, data can only be shared upon appropriate ethical amendment
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.
PubMed 39773121