Clinical trial NCT06234306: Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care
Official title: Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Bowel Adenocarcinoma
Keywords: Small bowel adenocarcinoma
messenger RNA
DNA
T-cell receptor sequencing
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Rigshospitalet, Denmark
name: University of Copenhagen
First posted: 2024-01-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with small bowel adenocarcinoma referred to management at participating centers

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Molecular characterization of patients with SBA using high-throughput DNA-, mRNA- and T-cell receptor sequencing and targeted protein expression analyses.
timeFrame: 5 years
Secondary outcomes:
measure: Prognostic and predictive DNA biomarkers in patients with SBA
timeFrame: 5 years
measure: Prognostic and predictive mRNA biomarkers in patients with SBA
timeFrame: 5 years
measure: Prognostic t-cell receptor biomarkers in patients with SBA
timeFrame: 5 years
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
city: Copenhagen Ø
country: Denmark
facility: Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Oncology Copenhagen University Hospital - Herlev and Gentofte
Study officials:
affiliation: Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte
name: Dan Høgdall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: