Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

Small Bowel Adenocarcinoma Clinical Trial

— SBAMOL  

Official title:

Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234306
• Other study ID #: 2312342
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2033

Study information

• Verified date: January 2024
• Source: Copenhagen University Hospital at Herlev
• Contact: Dan Høgdall, MD PhD
• Phone: 004538681954
• Email: danhog01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion criteria:

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Small Bowel Adenocarcinoma

Locations

Country	Name	City	State
Denmark	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

Sponsors (4)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Aarhus University Hospital, Rigshospitalet, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years