Métodos innovadores de detección del cáncer colorrectal para individuos de alto riesgo
Este estudio tiene como objetivo observar y evaluar nuevos métodos para el cribado del cáncer colorrectal en individuos de alto riesgo, evaluando riesgos genéticos y biomarcadores novedosos mediante muestras de frotis bucal, sangre, heces y aliento.
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades del colon+8
+ Enfermedades del Sistema Digestivo
+ Neoplasias del sistema digestivo
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 1 de agosto de 2024
Fecha en la que se inscribió al primer participante.Colorectal Cancer (CRC) is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women. CRC can often be prevented through regular screening. Although colonoscopy-based screening programs result in a significant decrease in CRC incidence, the compliance rate for performing the required screening remains too low and not the desired one. Fecal Occult Blood Test (FOBT) is another widely used screening modality for CRC but have certain constraints, such as relatively low sensitivity and the need for multiple sampling (three) to reach full screening potential. The development of novel, more practical screening methods can effectively increase the screening rates for CRC through non-invasive, repeatable, cost-effective, easy-to-use, and patient-friendly procedures. This is of particular importance in different European societies and population subgroups, since an increase in the incidence of Early-Onset CRC is currently noticed, which is significantly associated with risk factors such as heredity, obesity, smoking, alcohol abuse, and hyperlipidemia. Within this framework, ONCOSCREEN will develop a multi-tier diagnostic solution towards improved CRC screening. Furthermore, ONCOSCREEN will consider specific socio-economic determinants which increase the regional or national CRC risks, thus exploiting new solutions, particularly in younger high-risk individuals in European communities. For the validation of the developed solution, a clinical validation study (titled "ONCOSCREEN-CS") will be conducted to assess its effectiveness, sensitivity, and specificity in detecting CRC at an early stage. During the first phase of the study (ONCOSCREEN-CS-Phase A), the investigators will identify the different expression patterns of the four diagnostic solutions (ONCO-VOC, ONCO-CRISP, ONCO-NMR, ONCO-CTC) in CRC patients and healthy controls with high risk for CRC, and also initially estimate their sensitivity and specificity. During the second phase (ONCOSCREEN-CS-Phase B), the ONCOSCREEN solution will be clinically validated.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 4100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Condiciones
Patología
Criterios
Inclusion Criteria: * CRC Group 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥18 years 3. Subject is willing to undergo FOBT test, colonoscopy, and tissue biopsy 4. Subject for whom the decision to perform a colonoscopy has been made by the treating physician 5. Subject has positive CRC diagnosis according to colonoscopy result 6. Covered by a Health Insurance System 7. Subject is able to comply with all study procedures * Control Group with risks and presence of polyps 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥18 years 3. Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia. 4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy 5. Subject has negative CRC diagnosis according to colonoscopy result 6. Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool/rectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness. * Control Group with risks and absence of polyps 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥18 years 3. Otherwise healthy individuals with recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidaemia. 4. Subject be willing to undergo FOBT test, colonoscopy, and tissue biopsy 5. Subject has negative CRC diagnosis according to colonoscopy result 6. Covered by a Health Insurance System, which will cover colonoscopy as screening in patients with risk factors and alarm symptoms such as abdominal pain, change in stool texture, change in stool frequency, blood in stool/rectal bleeding, diarrhea, constipation, abdominal bloating, weight loss, tiredness. * Control Group with no risks 1. Signature of the informed consent indicating that the subject accepts to participate in the study and to comply with the requirements and restrictions inherent in this study. 2. Subjects aged ≥40 years 3. Otherwise healthy individuals without any recognized risk factors for CRC development defined by either heredity and/or obesity and/or smoking and/or excess alcohol consumption and/or hyperlipidemia. 4. Subject be willing to undergo FOBT test 5. Subject has negative FOBT result Exclusion Criteria: * For the CRC Group 1. Legal incapacity or limited legal capacity 2. Subject did not sign the Informed Consent form 3. Subject who, according to the investigator's assessment, presents with an unstable medical condition contraindicating the performance of the planned blood test, stool test or breath test 4. Subject has had surgery in the previous 6-8 weeks or is under medication for CRC treatment. * For the control groups 1. Legal incapacity or limited legal capacity 2. Subject did not sign the Informed Consent form 3. Previous history of any type of cancer 4. Gastrointestinal disorders or other serious acute or chronic diseases
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 8 ubicaciones
Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
Sofia, BulgariaAbrir Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria en Google MapsMKI UKSH Lübeck
Lübeck, GermanyUMC Mainz: University Medical Center Mainz
Mainz-GE, GermanyLSMU: Lithuanian University of Health Sciences Gastroenterology Department,
Kaunas, Lithuania