Molecularly Redefining Small Bowel Adenocarcinoma to Accelerate Precision Patient Care
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Small Bowel Adenocarcinoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Molecular characterization of patients with SBA using high-throughput DNA-, mRNA- and T-cell receptor sequencing and targeted protein expression analyses. [Срок оценки: 5 years]
Вторичные конечные точки (3)
- Prognostic and predictive DNA biomarkers in patients with SBA [Срок оценки: 5 years]
- Prognostic and predictive mRNA biomarkers in patients with SBA [Срок оценки: 5 years]
- Prognostic t-cell receptor biomarkers in patients with SBA [Срок оценки: 5 years]
Критерии участия
Критерии включения
Patients with histologically verified small bowel adenocarcinoma Patients older than 18 years
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Дания · 3 центра
- Department of Oncology, Aarhus University Hospital — Aarhus N
- Department Surgical Gastroenterology, Copenhagen University Hospital - Rigshospitalet — Copenhagen Ø
- Department of Oncology Copenhagen University Hospital - Herlev and Gentofte — Herlev
Публикации
- 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
Идентификаторы
NCT: NCT06234306 · 2312342