A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.
Colección de datos
Recopilados desde hoy en adelante - ProspectivoResumen
Fecha de inicio: 1 de noviembre de 2004
Fecha en la que se inscribió al primer participante.PURPOSE OF STUDY The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a treatment method that works by delivering radiation from inside the breast directly to the tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left after the tumor is removed). Radioactive sources (seed) are placed within the device by a computer controlled machine. This radioactive source will deliver the radiation therapy to the breast A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases. PROCEDURES If the patient agree to take part in this registry, data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits. POTENTIAL RISKS AND DISCOMFORTS There is no medical risk to the patient if she takes part in this registry, as she will continue to receive the same medical care as provided by her medical team. POTENTIAL BENEFITS: It is not possible to state that the patient will benefit from this study. The information obtained from study may be used scientifically and may possibly be helpful to others. ALTERNATIVES TO TREATMENT The patient participation is voluntary and she may choose not to participate in this study or she may stop at any time. The patient choice will not affect doctors from providing care. The patient will not lose any benefits if she choose not to participate or if you withdraw from this study. She is free to seek care from a doctor of her choice at any time.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 300 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 45 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.Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
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
St. Vincent's Medical Center
Bridgeport, United StatesAbrir St. Vincent's Medical Center en Google Maps