Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

NCT06234306 | Recruiting

• 1 other identifier: 2312342
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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. This effort is intended to lay the groundwork for personalized medicine tailored to this specific patient group.

Conditions

Small Bowel Adenocarcinoma

Keywords

Small bowel adenocarcinoma; messenger RNA; DNA; T-cell receptor sequencing

Outcome Measures

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.

  5 years

Secondary Outcomes (3)

• Prognostic and predictive DNA biomarkers in patients with SBA

  5 years

• Prognostic and predictive mRNA biomarkers in patients with SBA

  5 years

• Prognostic t-cell receptor biomarkers in patients with SBA

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with histologically verified small bowel adenocarcinoma Patients older than 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• Aarhus University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (3)

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet

Copenhagen Ø, 2100, Denmark

RECRUITING

Department of Oncology Copenhagen University Hospital - Herlev and Gentofte

Herlev, 2730, Denmark

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-Fixed, Paraffin-Embedded or fresh frozen tissue for DNA, RNA and geospatial analyses

Study Officials

• Dan Høgdall, MD PhD

  Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Høgdall, MD PhD

CONTACT

004538681954; danhog01@regionh.dk

Jakob HV Schou, MD

CONTACT

004538682985; jakob.hagen.vasehus.schou@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

DK (3)