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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU-99G8 | Other Identifier | Northwestern University IRB | |
| NCI-G00-1753 | Other Grant/Funding Number | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: To improve strategies for detection and prevention of early-stage disease.
PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk for Ovarian Cancer | Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic. |
| |
| Suspected or diagnosed gynecological condition | Women who are planning to undergo surgery for their gynecological condition | ||
| Control Group | Healthy subjects with no history of cancer and at general risk. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ca-125 | Other | Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other | To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| new prevention approaches and therapies for risk assessment | To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease. | 1 year |
| The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer |
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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:
Undergoing surgery for a gynecologic condition, including any of the following:
PATIENT CHARACTERISTICS:
Age
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Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takelia Walker | Contact | 3125034802 | takelia-watson@northwestern.edu | |
| Anne Grace | Contact | 312-503-4165 | anne@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lee P. Shulman, MD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting | Chicago | Illinois | 60611-3013 | United States |
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| Label | URL |
|---|---|
| Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Research | View source |
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Subject's blood and other specimens are collected their follow-up clinic appointments, as needed
| screening questionnaire administration | Other | Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected. |
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| Surgery | Procedure | Subjects will be assessed for high risk factors. |
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To identify the measurements to improve the quality of life for women at increased risk for developing the disease |
| 1 year |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D047708 | Myofibroma |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D001943 | Breast Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009372 | Neoplasms, Connective Tissue |
| D003240 | Connective Tissue Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D018394 | CA-125 Antigen |
| D011795 | Surveys and Questionnaires |
| D013514 | Surgical Procedures, Operative |
| D019328 | Buthionine Sulfoximine |
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D009077 | Mucins |
| D009088 | Mucoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015295 | Antigens, Tumor-Associated, Carbohydrate |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D000939 | Epitopes |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008717 | Methionine Sulfoximine |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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