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Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care

NCT ID: NCT06234306

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2033-12-31

Brief Summary

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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

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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.

Conditions

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Small Bowel Adenocarcinoma

Keywords

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Small bowel adenocarcinoma messenger RNA DNA T-cell receptor sequencing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Dan Hogdall

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Høgdall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte

Locations

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Department of Oncology, Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet

Copenhagen Ø, , Denmark

Site Status RECRUITING

Department of Oncology Copenhagen University Hospital - Herlev and Gentofte

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Dan Høgdall, MD PhD

Role: CONTACT

Phone: 004538681954

Email: [email protected]

Jakob HV Schou, MD

Role: CONTACT

Phone: 004538682985

Email: [email protected]

Facility Contacts

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Elizaveta M Tabaksblat, MD PhD

Role: primary

Carsten P Hansen, MD DMSc

Role: primary

Dan Hogdall, MD PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39773121 (View on PubMed)

Other Identifiers

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2312342

Identifier Type: -

Identifier Source: org_study_id