Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCopenhagen University Hospital at Herlev

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients diagnosed with small bowel adenocarcinoma referred to management at participating centers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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.

Time frame
5 years

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
5 years

Other outcomes

Sponsors and contacts

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Copenhagen University Hospital at Herlev

Lead sponsor

Aarhus University Hospital

Collaborator

Rigshospitalet, Denmark

Collaborator

University of Copenhagen

Collaborator