Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

This research study is designed to work in cooperation with another study being conducted by the National Cancer Institute. The National Cancer Institute (NCI) is studying the effects of a drug called raloxifene on premenopausal women believed to have a high risk of developing breast cancer (98-C-0123).

In this study, researchers are interested in learning about the effects of raloxifene on the uterus and ovaries of the women participating in the NCI study. To do this researchers plan to conduct ultrasounds on the patients enrolled in the NCI study. In addition researchers plan to take samples of the lining of the uterus in these patients (endometrial biopsy) if found to be necessary.

The purpose of this study is to determine the reproductive effects of raloxifene on women who have normal functioning ovaries by taking ultrasounds of the ovaries and lining of the uterus (endometrium).

Raloxifene is a selective estrogen receptor-modulating agent that has been recently approved by the FDA for the treatment of osteoporosis in postmenopausal patients. A phase II trial evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for developing breast cancer has been recently approved by the IRB (98-C-0123). In this protocol, for assessment of the effects of raloxifene on the endometrium and ovaries, patients are scheduled to be studied with transvaginal sonography and hysterosonography, once during their menstrual cycle at periodic intervals. They are also scheduled to have endometrial biopsies as indicated. It is known that all SERMs (clomiphene, tamoxifen and in one small study raloxifene) raise the area under the curve of estradiol levels throughout the cycle in premenopausal women. Our study is designed to study the reproductive effects of raloxifene in these young women with competent ovaries using sonography of the ovaries and endometrium, and correlating it with steroid hormone levels which would be obtained under protocol 98-C-0123.

Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients

Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer

National Institutes of Health Clinical Center (CC)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Subjects enrolled will undergo brachytherapy treatment in combination with EBRT. The maximum length of treatment will be 56 days. The treating physician will determine the appropriate course of treatment based on the physician's current practice or experience using Iridium-192 or Cesium HDR after-loaders to administer cervical brachytherapy treatments.

Subjects enrolled will be treated with approximately 80-90 Gy total treatment dose over 4-6 fractions. Examples of commonly used dose regimens in the US are listed in section 7.6.7. This study will include data collection from the initiation of EBRT through administration of the final Xoft Axxent treatment fraction, and at one (1) month and three (3) months.

Treatment with Electronic Brachytherapy

Lowndes Harrison, MD

The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.

Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.

Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

To assess occurrence rate of radiation toxicities through three (3) months of follow-up.

Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.

Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.

Icad, Inc.

Xoft, Inc.

Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.

Treatment

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Crystal Leonard, CCRP

diarrhea-mild

fatigue-mild

hot flashes-moderate

urinary track infection-mild

vaginal bleeding-mild

decreased neutrophils-mild

insomnia-mild

loss of appetite-mild

extremity weakness-mild

mucositis-mild

urinary frequency-mild

weight loss-mild

headache-moderate

chest pressure-moderate

light headed-moderate

mild skin erythema-mild

occasional burning with urination-mild

Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).

Safety - Adverse Event Rate and Severity

Device Performance

Frequency of Adverse Events in Participants (i.e.Safety)

Overall Study

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Syndrome

Leukemia

Melanoma

Preleukemia

Myelodysplastic Syndromes

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Bone Marrow Diseases

Precancerous Conditions

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Neuroendocrine Tumor

Neuroepithelioma

The SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date.

If a patient consents to allowing the use of their tumor tissue sample(s) for testing/analysis at a future date, their name and information will be stored electronically in a registry that will be managed by SCRI. SCRI may then use the information contained in this registry (such as disease indication, demographic information, etc.) at any time in the future to select tissue samples on which to perform testing/analyses.

Tissue Registry Study

Howard Burris, M.D.

Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.

Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.

This study will consist of a registry of patients who have agreed to allow their tissue sample(s) (even those taken prior to their participation in an SCRI-sponsored trial) to be used by the SCRI Oncology Research Consortium at some point in the future for testing and analysis of expression analysis and/or analysis of tumor markers. The registry will be contained in an electronic database, and will be sorted by disease indication. (Note: Patients will not be asked to return at a future date and have tissue samples collected; rather, SCRI will have the authorization to obtain pre-existing samples).

Potential retention of tissue blocks for future study.

SCRI Tissue Testing Registry

SCRI Development Innovations, LLC

Gland and Hormone Related Diseases

Digestive System Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Peritoneal Neoplasms

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma

Elise C Kohn, M.D.

This study will develop a blood test that can be used to predict a relapse of ovarian, peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study of proteins in living cells. The test will identify certain proteins that might represent a pattern, or "fingerprint," indicating increased risk of disease relapse.

Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is in remission may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, review of pathology report from surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (and chest if the cancer spread to the chest).

Participants have a clinic visit every 3 months for a physical examination (including a pelvic examination), blood draw for routine and research tests, and review of how they have been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the chest. When a patient has been in remission for 4 years, blood draws are done every 6 months and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT scans, or physical examination) end their participation in the study. Patients with an abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical removal of a piece of tumor tissue) for research purposes.

Background:

Over 80% of patients with advanced stage epithelial ovarian cancer will relapse

Serum biomarkers are needed for predictors of persistent disease and relapse

CA-125 is a less than satisfactory clinical tool for detecting relapse

A serum repository of samples from women with ovarian cancer is needed to develop and validate the multiple tests being created for ovarian cancer recurrence and screening.

Objectives:

To create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated

To determine the sensitivity and specificity of the proteomic signature profiles for relapse

To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease progression

To identify the temporal relationship between a rise in CA125 value versus the development of proteomic signature profiles of relapse.

To detect the impact of study participation on quality of life.

To collect epidemiological data for patients in the target population

Eligibility:

Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.

Entry within 12 weeks of last administration of chemotherapy.

S/P surgical debulking and completion of primary therapy with platinum/taxane-containing chemotherapy of no more than a total of 8 cycles.

Laboratory evidence of good end organ function.

Design:

Phase of Trial: Biomarker/Laboratory Analysis.

Number of patients to be enrolled: 400

Planned statistical analysis for primary endpoint: Training set to include 100 women, half of whom are in remission and half of whom have recurrent disease. Validation set will include 200 women, half of whom are in remission and half of whom have recurrent disease.

Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers

A Multi-Institutional Study of Proteomic Evaluation of Epithelial Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile of Relapse

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients	NCT00001837	Breast Cancer Breast Neoplasm		-	National Institutes of Health Clinical Center (CC)
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer	NCT01851772	Cervical Cancer	Treatment with ...	-	Xoft, Inc.
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer	NCT01851772	Cervical Cancer	Treatment with ...	-	Xoft, Inc.
SCRI Tissue Testing Registry	NCT00965861	Melanoma Myelodysplastic... Multiple Myelom... Lymphoma	Tissue Registry...	18 Years -	SCRI Development Innovations, LLC
Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers	NCT00086567	Fallopian Tube ... Peritoneal Neop... Epithelial Ovar...		18 Years -	National Institutes of Health Clinical Center (CC)
Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers	NCT00086567	Fallopian Tube ... Peritoneal Neop... Epithelial Ovar...		18 Years -	National Institutes of Health Clinical Center (CC)
Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers	NCT00086567	Fallopian Tube ... Peritoneal Neop... Epithelial Ovar...		18 Years -	National Institutes of Health Clinical Center (CC)
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer	NCT01851772	Cervical Cancer	Treatment with ...	-	Xoft, Inc.

Spots Global Cancer Trial Database for gynecologic

Every month we try and update this database with for gynecologic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gynecologic

Every month we try and update this database with for gynecologic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gynecologic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.