Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Britton L Trabert, Ph.D.

This study, sponsored by NCI and the Gynecologic Oncology Group (GOG), will collect tissue samples from women with cancer of the endometrium (lining of the uterus). Researchers will use the samples to learn more about endometrial cancer and develop new treatments and methods of prevention.

Women with endometrial cancer who are suitable candidates for surgery and who have not had prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, and endometrial biopsy (surgical removal of a small tissue sample) or dilation and curettage (D \& C).

Participants will undergo hysterectomy (surgery to remove the uterus) along with removal of both fallopian tubes and ovaries. This is the standard surgical treatment for endometrial cancer. Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed to determine if the disease has spread to these nodes. If cancer is found involving other sites, the cancer in those areas may also be removed; examination of the tissues will determine if further therapy beyond surgery is needed.

Before surgery, patients will complete a 20-minute questionnaire that includes questions about their background, reproductive history, menstruation and menopause, certain surgeries, birth control pills and hormone replacement therapy, other drugs and medicines, weight and height, smoking, medical history, and family history of cancer.

Some of the tissue removed during surgery, plus a urine sample collected from a catheter bag during surgery, and blood drawn before surgery and at follow-up visits 6 weeks and 3 years after surgery, will be sent to the GOG Tissue Bank in Columbus, Ohio. This bank stores, processes, and distributes biological specimens from patients that agree to participate in studies conducted by the GOG.

Patients will have follow-up visits 6 weeks after surgery, then every 6 months for the next 2 years, followed annually for the next 7 years, for a total 10-year follow-up. The visits will include an examination and questions about health status and treatments received between visits. Patients whose cancer returns or worsens will undergo another tumor biopsy, if possible, at that time.

GOG-210 is a molecular and surgico-pathological staging study of endometrial carcinoma. The overall goal of this pilot protocol is to improve outcome and/or quality of life for patients with endometrial cancer. This fundamental goal will be accomplished through the development of more accurate models of risk, identification of candidate targets for therapeutic intervention and utilization of individualized treatments based on molecular characteristics identified in tumor tissue, normal tissue and/or in readily accessible biological fluids, like serum and urine. This molecular and surgico-pathological staging study is structured to collect tissue, urine, serum, and epidemiologic and clinical data from approximately 3,500 patients with endometrial cancer identified at participating GOG institutions. All of the patients will be surgically-pathologically staged, consistently evaluated, further treated as needed, and followed for up to 10 years after surgery to document further treatment and outcome. A series of independent and integrated research projects will be undertaken to utilize high-throughput methodologies (e.g., genomics and proteomics) and more traditional techniques (e.g., immunoassays) to examine cellular and extracellular factors, including chromosomes, DNA, RNA, proteins, lipids and carbohydrates. The results obtained from the comprehensive laboratory testing performed on these clinical specimens with the clinical and epidemiologic data collected for each GOG-0210 patient will represent an enduring resource for endometrial cancer research to study the factors that control the growth and spread of endometrial cancer, and how to predict response to therapy and risk of disease spread, recurrence and overall survival for patients with this disease. This will be the first implementation of the NCI-developed epidemiologic questionnaire, which will allow GOG protocols to systematically and uniformly collect demographic and epidemiologic data that will enhance the analytic capabilities of this study. If successful, this study will serve as a model for other protocol to implement the same epidemiologic questionnaire.

Molecular Staging of Endometrial Cancer

Integration of an Epidemiologic Questionnaire Into Gynecologic Oncology Group Trials: First Project, Protocol 210

National Cancer Institute (NCI)

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Cari M Kitahara

The etiology of brain tumors is poorly understood. Due, in part, to public concern about a postulated relationship between the use of cellular telephones or other increasingly prevalent environmental exposures and the incidence of brain cancer in adults, the National Cancer Institute is collaborating with three U.S. hospitals in a comprehensive case-control study of malignant and benign brain tumors. Factors under consideration include use of cellular phones and other wireless communication devices, workplace exposures to chemical agents and electromagnetic fields, dietary factors, family history of tumors, genetic determinants of susceptibility, home appliance use, reproductive history and hormonal exposures, viruses, medical and dental exposure to ionizing radiation, and other aspects of medical history.

Approximately 800 newly diagnosed brain tumor cases and 800 controls have been enrolled at hospitals in Boston, Phoenix and Pittsburgh. Cases include all adults (age greater than or equal to 18 years) newly diagnosed with a histologically confirmed intracranial glioma, intracranial meningioma or acoustic neuroma. Controls are patients admitted to the same hospitals as the cases, and treated for any of a variety of non-malignant conditions. Participating cases and controls were interviewed in the hospital by a research nurse and asked to complete a self-administered questionnaire and donate a sample of blood. Key features of the study include its large size, the emphasis on rapid ascertainment of incident cases and interview of study subjects rather than surrogate respondents, the use of detailed, job-specific questions developed by industrial hygienists to ascertain occupational exposures, and the storage of blood samples for future evaluation of inherited susceptibility, biomarkers of exposure and gene-environment interactions.

Implementation of the study protocol proceeded without serious problems. There have been no harmful effects on study participants. There have been no complaints from participants or breaches of confidentiality. Continuation of this research involves analysis and reporting of results. As there will be many papers, this process is expected to extend over the next several years.

The etiology of brain tumors is poorly understood. Due, in part, to public concern about a postulated relationship between the use of cellular telephones or other increasingly prevalent environmental exposures and the incidence of brain cancer in adults. The National Cancer Institute is collaborating with three US hospitals in a comprehensive case-control study of malignant and benign brain tumors. Factors under consideration include the use of cellular phones and other wireless communication devices, workplace exposures to chemical agents and electromagnetic fields, dietary factors, family history of tumors, genetic determinants of susceptibility, home appliance use, reproductive history and hormonal exposures, viruses, medical and dental exposures to ionizing radiation, and other aspects of medical history.

Approximately 800 newly diagnosed brain tumor cases and 800 controls have been enrolled at hospitals in Boston, Phoenix, and Pittsburgh. Cases include all adults (age age greater than or equal to 18 years) newly diagnosed with a histologically confirmed intracranial giloma, intracranial meningioma or acoustic neuroma. Controls are patients admitted to the same hospitals as the cases, and treated for any of a variety of non-malignant conditions. Participating cases and controls were interviewed in the hospital by a research nurse and asked to complete a self-administered questionnaire and donate a sample of blood. Key features of the study include its large size, the emphasis on rapid ascertainment of incident cases and interview of study subjects rather than surrogate respondents, the use of detailed, job-specific questions developed by industrial hygienists to ascertain occupational exposures and gene-environment interactions.

Implementation of the study protocol proceeded without serious problems. There have been no harmful effects on study participants. There have been no complaints from participants or breaches of confidentiality. Continuation of this research involves analysis and reporting of results. Numerous publications have resulted from the study and analyses are ongoing.

A Case-Referent Study of Brain Tumors in Adults

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health (NIOSH/CDC)

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Hormones

The Columbia MO Serum Bank recruited 6915 women living in and around Columbia MO between 1977-1987 who were cancer-free except for non-melanoma skin cancer and at least 18 years of age.

Gretchen Benson, Ph.D.

The Columbia, MO Serum Bank initially was established in 1977 as part of the National Cancer Institute's (NCI) Biological Markers Project to identify serum markers for breast cancer. Participants were volunteers identified through the Breast Cancer Detection Demonstration Project (BCDDP) at the University of Missouri Hospital and Ellis Fischel Cancer Center in Columbia, MO. A total of 6,915 women without a prior history of cancer, other than non-melanoma skin cancer, donated blood to the bank on one or more occasions between 1977 and 1987.

At the time of each blood collection, interview information was obtained including age, height, weight, reproductive and menstrual histories, family history of breast cancer, medical conditions, and drug use, including oral contraceptives and menopausal hormone therapy. Date of last menstrual period was captured for women who were premenopausal at the time of each blood collection. Approximately 30% of the women donated multiple samples over the first 10 years of the study, (including 20% with 3 or more samples), with collections occurring on average one year apart. At each collection, serum was aliquoted into up to ten, 1 ml vials and stored at -70 (Infinite)C at the NCI Repository. All women gave informed consent before donating to the serum bank.

The initial follow-up continued for up to 12 years through 1989, with 244 cancers identified. Of the 6915 original participants, 79% were last seen in 1983 or earlier, yielding a median follow-up time of 4 years. A questionnaire was mailed to all participants annually to ascertain information on interim breast biopsies and cancer diagnoses. Women who indicated that they had a breast biopsy or breast cancer were sent a consent form for permission to obtain medical records including pathology reports. For cancers at sites other than the breast, medical records and pathology reports were not requested, although date of diagnosis and site were ascertained.

Between 1999 and 2002, an extended follow-up of Columbia, MO Serum Bank participants was conducted. Of the 6915 original participants, 6,720 women had blood remaining and were included in this phase of the study. Of these, 6,154 (91.6%) were located; 566 (8%) were not locatable, 109 (2%) refused to participate, and 40 (\<1%) were too ill to participate. 1,694 women (25%) were deceased. This last follow-up identified an additional 1123 cancers. This cohort has serum samples from a cohort of 6720 pre- and postmenopausal women followed up to 20 years for cancer diagnoses and is a unique resource for molecular epidemiologic studies exploring serum markers associated with cancer risk.

Extended Follow-up of Columbia, MO Serum Bank Participants

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Patients diagnosed with Multiple Myeloma and healthy controls.

Questionnaire taking 30-40 minutes to complete.

Questionnaire

Michelle Hildebrandt, PhD

Objectives:

The overall objective of this project is to identify risk factors associated with the development of multiple myeloma (MM) by integrating epidemiologic, clinical and molecular information. We plan to invite MDACC patients with MM, as well as controls, to participate in this investigative case-control study. Controls will be selected from friends and spouses who accompany patients to the various MDACC clinics and will be matched to the cases on age (±5 years), gender, and ethnicity. We will obtain demographic, risk factor and clinical information along with a blood and buccal sample from all cases and controls. This study could have implications for prevention and subsequent reduction in the incidence of multiple myeloma. Collecting blood and buccal samples will allow us to study the role genetic susceptibility plays in MM risk. The specific aims are:

1. To enroll and obtain, through self-administered questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic, and behavioral profiles. This study will accrue 250 MM patients from MDACC and 250 healthy controls selected from friends and spouses who accompany patients to the MDACC clinics. Blood (25 ml) and buccal samples will be collected from all participants.
2. To identify risk factors associated with MM by integrating epidemiological, clinical and molecular information using a case-control approach.
3. To evaluate constitutional markers of genetic susceptibility as predictors of MM risk. Gene-environment interactions will be explored.

Informed Consent For Control Subjects:

In this study, researchers are trying to learn about factors that may be associated with MM.

For this study, you will be asked to complete a questionnaire. The questionnaire asks questions about your demographics (for example, age and sex), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your history of smoking and/or alcohol use. It should take around 30-40 minutes to complete the questionnaire.

Blood (about 2-3 tablespoons) will be drawn. You will spit into a collection container in order to provide a sample of your saliva. The blood and saliva samples will be used for special tests to look for any biological factors associated with MM.

If you live in Houston or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.

You will be considered off-study after the data that is collected has been processed.

This is an investigational study. Up to 500 participants will take part in this study. All will be enrolled at M. D. Anderson.

Informed Consent for Patients:

In this study, researchers are trying to learn about factors that may be associated with MM.

For this study, you will be asked to complete a questionnaire. The questionnaire asks questions about your demographics (for example, age and sex), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your history of smoking and/or alcohol use. It should take around 30-40 minutes to complete the questionnaire.

Blood (about 2-3 tablespoons) will be drawn. You will spit into a collection container in order to provide a sample of your saliva. The blood and saliva samples will be used for special tests to look for any biological factors associated with MM.

If you live in Houston or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.

Neither you nor your doctor will receive the results of these tests, and they will not be put in your medical record.

You will be considered off study after the data that is collected has been processed.

This is an investigational study. Up to 500 participants will take part in this study. All will be enrolled at M. D. Anderson.

Blood and saliva samples that will be used for special tests to look for any biological factors associated with Multiple Myeloma (MM).

Etiology of Multiple Myeloma: A Case-Control Study

M.D. Anderson Cancer Center

Symptoms and General Pathology

Carcinogenesis

Nicolas Wentzensen, M.D.

Background:

* Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic cancer in the United States.
* Currently, there are no markers (components of blood and tissue that determine who might be at risk for developing cancer) for endometrial cancer.

Objectives:

-To see if women who are undergoing hysterectomy are willing to provide blood and tissue samples to help doctors identify markers that would indicate increased risk for developing endometrial cancer.

Eligibility:

-Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others at Magee-Women's Hospital in Pittsburgh, Penn.

Design:

* Patients' medical records are reviewed and patients complete a questionnaire including information on race and ethnic background, education, marital status, family history, height, weight, pregnancy history, smoking history, medication history, history about menstrual periods and menopausal symptoms.
* Patients provide blood and urine samples before surgery.
* A sample of fat tissue is removed during surgery in patients undergoing abdominal surgery.
* Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are collected and analyzed for markers for endometrial cancer.

Our hypothesis is that silent molecular lesions, defined as molecular alterations

detectable in histologically normal endometrial, ovarian, and tubal tissues, represent markers of cancer risk. Incessant ovulation represents one of the most widely-recognized models to explain the pathogenesis of ovarian cancer, with women who have had a high number of lifetime ovulatory menstrual cycles being at increased cancer risk because of repeated ovulation-related injury to, and repair of, ovarian surface epithelium (OSE). This extremely delicate single layer of cells exfoliates easily on handling, with the majority of cells typically being lost in routine handling, when collected post-operatively. Furthermore, the identification of early stage ovarian cancer is uncommon, and the vast majority of ovarian cancers are not associated with recognizable precursors. The lack of effective techniques for collecting and studying OSE in the laboratory represents a major barrier to molecular studies designed to uncover the etiology and early pathogenesis of ovarian cancer. This proposal will develop a collection method for OSE, and demonstrate its utility for various molecular analyses. Recent evidence suggests that a subset of ovarian cancers may originate in the fallopian tubes. Therefore, we will pilot the collection of cells from the fallopian tubes. If successful, the collection of OSE and fallopian tube cells will provide the basis for larger studies aimed at identifying early molecular events in ovarian carcinogenesis.

In this pilot, we will collect endometrial and ovarian tissues (that would otherwise have been discarded without histopathologic examination) from 125 hysterectomy and/or unilateral or bilateral oophorectomy specimens obtained from women ages 18 and older who were operated on for benign indications. As an amendment to this active protocol, we propose demonstrating the feasibility of obtaining intra-operative cytobrushings of ovarian surface epithelial cells on 50 women to be accrued onto the study, which will include women having hysterectomy (or unilateral oophorectomy) alone without removal of the ovaries at the time of surgery. Furthermore, we will extend the collection to cells from the fallopian tubes in 225 women for a total population of 400.

We will administer a questionnaire assessing endometrial and ovarian cancer risk factors and gynecologic history; obtain blood and urine; and obtain carefully-mapped frozen and fixed endometrial and ovarian tissues. We will immunostain endometrial tissues to assess the presence, number, location, and size of foci containing PTEN-null glands, which represents a validated surrogate of mutations in the PTEN tumor suppressor gene. This pilot will demonstrate the feasibility of executing this complex protocol; determine the number and spacing of sections required to accurately and efficiently assess the PTEN status of the endometrium; and provide data for developing power estimates needed to propose a full-scale study with a sufficient number of subjects to test our hypothesis that PTEN abnormalities account for a substantial proportion of the risk associated with recognized epidemiologic endometrial cancer risk factors. It will assess the feasibility of performing molecular analyses on ovarian surface epithelial cells and tubal cells collected intra-operatively, and correlating molecular findings with known ovarian cancer risk factors. If successful, this will provide the basis for larger studies aimed at identifying early molecular events in

ovarian carcinogenesis, particularly in the setting of women at increased genetic

risk of ovarian cancer. The pilot itself will also provide an extremely valuable

repository for future biomarker pilot studies.

Benign Reproductive Tissue Analysis for Endometrial Cancer Markers

Benign Reproductive Tissue Evaluation (BRTE) Study

Successful enrollment of women undergoing benign surgery, surgery because of high risk of ovarian cancer, or surgery because of diagnosed ovarian cancer.

Histological assessment of PTEN staining in normal endometrial tissues.

Improvement of PTEN staining after modifying the immunohistochemical staining protocol.

Pilot testing of other assays on tissue and cytology samples.

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Cohort of adults from Golestan region in Iran

Christian Abnet, Ph.D.

Background:

-Esophageal cancer is the most common cancer in Iran s Golestan Province. Nutritional deficiencies, ethnicity and environmental exposures might contribute to the development of this disease.

Objectives:

-To better understand the cause of esophageal cancer in Golestan Province and to reduce its occurrence there.

Eligibility:

-Adults from the Gonbad, Aq-Qala and Kalaleh districts of eastern Golestan Province in Iran.

Design:

* The study is a collaboration between NIH, the Digestive Disease Research Center of Teheran University of Medical Sciences, and the International Agency for Research on Cancer.
* Participants complete a lifestyle questionnaire and food frequency questionnaire.
* Samples of participants blood, urine, hair and toenail clippings are obtained.

Esophageal cancer is the sixth most common cause of cancer death worldwide, killing over 380,000 people each year. Over 80% of esophageal cancers occur in developing countries, where the great majority of cases are squamous cell carcinomas. Esophageal cancer is characterized by striking geographic variation in incidence. One remarkable high-risk area, called the Central Asian Esophageal Cancer Belt, stretches from the Caspian Sea across Central Asia to northern China and includes focal areas with recorded incidence rates greater than 100/10s/year in both genders. For the past 20 years, D CEG investigators have studied esophageal and gastric cancer in one of these extremely high-risk areas, Linxian, China, at the eastern end of the Belt. While these studies have discovered new risk factors for esophageal cancer in this region, they have produced an incomplete explanation of the etiology of this disease. Now we have the opportunity to perform similar studies in another of these extremely high-risk areas, Golestan Province, Iran, at the other end of the high-risk Belt. The people of Golestan, in northeastern Iran, are geographically, culturally and ethnically quite different from the people of Linxian, and they appear to be similar only in their extraordinarily high rates of esophageal cancer. Performing similar studies in these two exceptional populations will give us a better chance to identify important new modifiable risk factors for esophageal cancer in both places.

Our cohort study is a collaboration between the Digestive Disease Research Center of Tehran University of Medical Sciences (DDRC), the International Agency for Research on Cancer (IARC), and DCEG. The study has recruited 50,000 adults in three administrative districts of eastern Golestan Province. Baseline assessments included lifestyle questionnaire, a semi-quantitative food frequency questionnaire, and collection of blood, hair, nails and urine. Follow up will includes active surveillance by a study team, aided by a comprehensive health network in the rural areas, a GI referral clinic in the largest town, and a provincial cancer registry. The main hypotheses include dietary hypotheses (low consumption of fruits and vegetables, high consumption of hot tea), exposure to potential carcinogens (tobacco, PAHs from non-tobacco sources), novel exposures (opium, animal contact), and genetic susceptibility. Some cross sectional and a few total mortality analyses have been completed. Annual follow-up is ongoing.

Esophageal Cancer in Northeastern Iran

The Golestan Cohort Study of Esophageal Cancer

The main hypotheses include dietary hypotheses (low consumption of fruits and vegetables, high consumption of hot tea), exposure to potential carcinogens (tobacco, PAHs from non-tobacco sources), novel exposures (opium, animal contact), and genetic susceptibility.

Some cross sectional and a few total mortality analyses have been completed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Staging of Endometrial Cancer	NCT00340808	Endometrial Can...		18 Years -	National Institutes of Health Clinical Center (CC)
A Case-Referent Study of Brain Tumors in Adults	NCT00339300	Brain Tumors		18 Years - 90 Years	National Institutes of Health Clinical Center (CC)
Extended Follow-up of Columbia, MO Serum Bank Participants	NCT00340210	Breast Cancer Endometrial Can... Ovarian Cancer		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Etiology of Multiple Myeloma: A Case-Control Study	NCT00505999	Multiple Myelom...	Questionnaire	-	M.D. Anderson Cancer Center
Molecular Staging of Endometrial Cancer	NCT00340808	Endometrial Can...		18 Years -	National Institutes of Health Clinical Center (CC)
Benign Reproductive Tissue Analysis for Endometrial Cancer Markers	NCT00481754	Oophorectomy fo... Hysterectomy		18 Years - 54 Years	National Institutes of Health Clinical Center (CC)
Esophageal Cancer in Northeastern Iran	NCT00450788	Esophageal Canc... GI Disease		30 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Benign Reproductive Tissue Analysis for Endometrial Cancer Markers	NCT00481754	Oophorectomy fo... Hysterectomy		18 Years - 54 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for etiology

Every month we try and update this database with for etiology 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 etiology

Every month we try and update this database with for etiology 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 etiology 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.