Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
Colección de datos
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Recopilados desde hoy en adelante - ProspectivoEnfermedades Urogenitales+33
+ Enfermedades Genitales
+ Enfermedades Anexiales
Otro
Uso de métodos específicos que no están cubiertos por los modelos estándar para abordar preguntas de investigación únicas.Resumen
Fecha de inicio: 1 de marzo de 2000
Fecha en la que se inscribió al primer participante.OBJECTIVES: To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies. To identify new prevention approaches and therapies. To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer. OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer. The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified. Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 6000 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.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Meets one of the following criteria: Considered to be at increased risk for developing ovarian cancer, as defined by one of the following: Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer Increased risk as deemed by a certified genetic counselor Undergoing surgery for a gynecologic condition, including any of the following: Diagnosis of a reproductive cancer Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts) Highly suspicious adnexal mass Risk-reducing prophylactic oophorectomy PATIENT CHARACTERISTICS: Age Between the ages of 18 and 80
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesAbrir Robert H. Lurie Comprehensive Cancer Center at Northwestern University en Google Maps