Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

Recruiting

• Conditions: Small Bowel Adenocarcinoma

• Registration Number: NCT06234306
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular characterization of patients with SBA using high-throughput DNA-, mRNA- and T-cell receptor sequencing and targeted protein expression analyses.	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Prognostic and predictive DNA biomarkers in patients with SBA	5 years	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.
Prognostic and predictive mRNA biomarkers in patients with SBA	5 years	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.
Prognostic t-cell receptor biomarkers in patients with SBA	5 years	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.

Trial Locations

Locations (3)

Department of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet; 🇩🇰 Copenhagen Ø, Denmark

Department of Oncology Copenhagen University Hospital - Herlev and Gentofte; 🇩🇰 Herlev, Denmark