Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
Data Collection
+ other Data
+ procedure Data
Collected from today forward - ProspectiveUrogenital Diseases+40
+ Genital Diseases
+ Adnexal Diseases
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: March 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Google Maps