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  • Assessment of Screening Modalities for Gynecologic Cancers Rochester, Minn.

    Background:

    • Endometrial and ovarian cancers are, respectively, the fourth and eighth most common cancers among women in the United States. Although some routine Pap tests may detect the presence of cancer cells, there are no convincing early detection approaches for either cancer. Better methods of detection are needed.
    • Two possible methods for cancer detection involve samples taken with a tampon or a special kind of brush, called a Tao brush. Researchers would like to know more about how well these methods work.

    Objectives:

    • To assess the quality of DNA collected by the tampon and Tao brush sampling methods.
    • To detect genetic markers in collected DNA and determine if these markers are related to an individual s cancer status.

    Eligibility:

    • Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer, who will be having surgery.
    • A control group of postmenopausal women having surgery for benign gynecological conditions will be included.

    Design:

    • Shortly before hysterectomy or more extensive procedures to treat either cancer or the benign condition:
    • A tampon will be inserted into the vagina to collect cell samples, and removed after 30 minutes.
    • After the tampon is removed, the cervix will be swabbed with the Tao brush to collect cell samples.
    • Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and tested by researchers.
  • Description of perceived cancer risk, screening, and risk reduction practices among women with Lynch syndrome Rochester, Minn. This is a survey study to describe how women with Lynch syndrome are being screened for gynecologic cancer risk, their perception of cancer risk, and uptake of risk reducing surgery.
  • Methylation Markers for Natural History and Early Detection of Endometrial Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to collect vaginal and endometrial cell samples to study endometrial cancer.

Closed for Enrollment

  • A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus Rochester, Minn.

    Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system. We have examined this fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian cancer when compared against healthy controls. These markers will be initially refined using the comparison of ovarian cancer patients against those with benign adnexal masses that entered the clinic during the same time period. In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.

  • A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Rochester, Minn., La Crosse, Wis., Mankato, Minn., Scottsdale/Phoenix, Ariz.

    This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

  • A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy. Rochester, Minn. Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
  • A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS) (COCOS) La Crosse, Wis., Rochester, Minn., Mankato, Minn.

    The purpose of this study is to see how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

  • Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial Rochester, Minn.

    This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

  • Analyzing gene expression in human endometriosis Rochester, Minn.

    The purpose of this study is to examine the gene expression within endometriosis.

  • GOG-3005: A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Rochester, Minn.

    The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

  • Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study Rochester, Minn., Mankato, Minn., Eau Claire, Wis., Albert Lea, Minn., La Crosse, Wis. This observational trial studies how well surgery to remove the tumor and lymph nodes, and/or radiation therapy work in treating patients with early-stage vulvar cancer. Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery and/or radiation therapy are in treating vulvar cancer.
  • Methylation Markers for Natural History and Early Detection of Endometrial Cancer (TT Study) Rochester, Minn.

    Background:

    • Endometrial cancer is one of the most common gynecologic cancers. If it is caught at an early stage, it can be treated more easily. Women who have this type of cancer often have a history of irregular menstrual bleeding. They may also have abnormal findings during gynecologic exams. Pap smears and cervical cell collection may be able to collect cell samples for cancer testing. However, samples from the vagina or endometrium may produce more accurate results. Researchers want to collect vaginal and endometrial cell samples to improve their tests for and understanding of endometrial cancer.

    Objectives:

    • To collect vaginal and endometrial cell samples to study endometrial cancer.

    Eligibility:

    • Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal bleeding, or abnormal ultrasound findings.

    Design:

    • Participants will be screened with a physical exam and medical history.
    • Participants will have a pelvic exam. Before the exam, they will insert a small tampon in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon will then be removed and collected for the study.
    • During the pelvic exam, tissue will be collected from the uterine lining with a special brush. An additional sample (biopsy) will be collected from the lining.
    • A blood sample will also be collected as part of the study.
  • Methylation Profiling of Normal Lower Gynecological Tract Tissues Rochester, Minn.

    The goal of this study is to identify methylation patterns in benign lower gynecologic tract tissues by performing global methylation analyses of benign cervico-vaginal squamous tissue. It will also determine methylation pattern for the cervico-vaginal environment through global methylation analyses of cervico-vaginal cytologic scrapings and brushings.

  • Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers Rochester, Minn.

    This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.

  • Prospective Quality Improvement Project Evaluating the Feasibility and Safety of Adnexal Surgery at the time of Vaginal Hysterectomy Rochester, Minn.

    The goal of this project is to show that removal of the fallopian tubes at the time of vaginal hysterectomy is not only possible, but does not significantly increase the morbidity of the procedure.

  • Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers: A Pilot Study Rochester, Minn.

    The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy

  • WISP (Women Choosing Surgical Prevention) (WISP) Rochester, Minn.

    The goal of this clinical research study is to compare the changes in female sexual function between patients having interval salpingectomy with delayed oophorectomy (ISDO) with those having risk-reducing salpingo-oophorectomy (RRSO) in women who carry genetic mutations. Researchers also want to learn how these surgeries affect your quality of life. RRSO is the standard surgery for patients with certain types of genetic mutations, where the fallopian tubes and ovaries are removed at the same time. ISDO is surgery to remove the fallopian tubes first, then the ovaries are removed during a second, later surgery. Most women with genetic mutations will be encouraged to remove the ovaries around the ages of 40 to 50. The decision in timing to remove your ovaries will be made with your doctor.

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