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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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.

Dan Høgdall, MD PhD contact

004538681954

danhog01@regionh.dk

Denmark3 sites, 3 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

    Recruiting

Other trials in Denmark

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.

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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted31 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2033 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

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)
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

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