Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
Colección de datos
Neoplasias
+ Neoplasias por tipo histológico
+ Sarcoma
Otro
Uso de métodos específicos que no están cubiertos por los modelos estándar para abordar preguntas de investigación únicas.Resumen
Fecha de inicio: 18 de junio de 2019
Fecha en la que se inscribió al primer participante.In the proposed study, the investigators wish to prospectively collect blood samples from 25 patients with localized soft tissue sarcomas and 25 patients with metastatic sarcoma (schema III) at various time points outlined. The presence/absence, as well as the change of ctDNA in circulation, will then be measured after the therapies administered and correlated with overall survival, progression-free survival and local control. The risks to the subjects enrolled on this study include the general risks of undergoing the standard procedures, such as blood draws, imaging, radiation therapy, chemotherapy and surgery, which will be discussed prior to the therapies and images each patient undergoes. The risks of the procedures are not risks of the study with exception to blood draws. There is also a risk of loss of confidentiality, but the data will be deidentified once acquired. Thus, this risk is minimal.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro
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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation. * Diagnosis of soft tissue sarcoma. * ≥ 18 years of age. * Planned biopsy obtained within four weeks after registration. * History and physical within eight weeks prior to registration. * For stage II-III patients, no prior therapy to primary site of sarcoma. * Computerized tomography (CT), positron emission tomography (PET) /CT or MR imaging of the affected primary site obtained in stage II-III or metastatic site in stage IV patients within eight weeks prior to registration. * CT chest or PET /CT acquired to assess distant disease within eight weeks prior to registration for stage II-III patients. * Karnofsky Performance Scale (KPS) 60 or above within four weeks prior to registration. * Documentation of stage within eight weeks prior to registration. * Biopsy of primary or metastatic disease site must be safe, feasible and in concordance with standard of care per the treating physician and/or radiologist. * Life expectancy ≥ 12 weeks. Exclusion Criteria: * Pregnant women. * Patients with a history of metastatic disease from a primary other than sarcoma. * Patients who cannot undergo imaging as part of treatment planning or surveillance.
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 una ubicación
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, United StatesAbrir Froedtert Hospital & the Medical College of Wisconsin en Google Maps