Continuation of Follow-up of DES-Exposed Cohorts
Breast CancerAutoimmune Disease3 moreDiethylstilbestrol (DES), a drug first synthesized in 1938, was administered to several million pregnant women in the U.S. and Europe for the prevention of spontaneous abortion and premature delivery. In 1971, Herbst reported a strong association between DES use in pregnancy and the occurrence of vaginal clear cell adenocarcinoma (CCA) in exposed female offspring. Animal models have demonstrated a range of DES effects on offspring exposed in utero, including reproductive dysfunction, immune system changes, behavioral and sexual abnormalities, and increases in various reproductive cancers in males and females. In the mid-1970's, several separate cohorts of DES-exposed daughters and unexposed comparison groups were followed for the occurrence of cancer, precursor lesions, and reproductive effects, but systematic follow-up of these cohorts had ceased by 1990. In 1992, Congress passed a bill (H;.R. 4178) mandating the continued follow-up of DES-exposed cohorts. The National Cancer Institute, in collaboration with five field centers, reassembled previously studied cohorts of DES-exposed and unexposed mothers, daughters and sons, and identified subjects with documented exposure status who had not been studied previously, through familial links within the cohorts. Standardized baseline questionnaires were mailed to cohort members to ascertain the risk of cancer and other disorders. Pathology reports were collected for reported cancers and preneoplastic conditions. Two separate rounds of follow up have been conducted and a third is almost complete. Patients from the Registry for Research on Hormonal Transplacental Carcinogenesis (the Registry) will be added to the follow-up effort in the third phase. The purpose of this study is to continue the follow-up, by means of mail questionnaires and medical record collection, which was begun during the first phase of the study. Concern has arisen that DES-exposed daughters may be at higher risk of breast cancer. Exposure to high levels of endogenous estrogen in utero has been hypothesized to increase the risk of breast cancer and DES is a potent estrogen. Cancer risk in the sons will also continue to be assessed, especially for increased risks of prostate cancer. Since the offspring who were exposed to DES in utero are currently reaching their late forties, when cancer rates begin to rise, it is important to continue the follow-up of these cohorts to determine if there are long-term increases in cancer risk.
The Longitudinal Evaluation of Autoimmune Pulmonary Alveolar Proteinosis
Autoimmune Pulmonary Alveolar ProteinosisThe major goal of this study is to conduct a prospective, longitudinal study of autoimmune PAP to examine outcome measures for disease severity of potential use in clinical practice and/or clinical research studies. These results will impact the field by: 1) improving an understanding of the clinical course of autoimmune PAP, 2) providing information on various clinical outcome and quality of life outcome measures to guide patients and physicians in making treatment choices, and 3) facilitate the development of pharmaco-therapeutics for autoimmune PAP and 4) better informing PAP researchers.
Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab
Autoimmune DiseasesRituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases. The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United...
InfectionsPapillomavirusThis is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts. This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.
EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients
Autoimmune DiseasesThe purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by different study protocols used across Europe in various EBMT centres through the careful recording and analysis of routinely collected clinical and biological data.
Study of Oral Bacteria in Patients With Dry Mouth
XerostomiaAutoimmune DiseasesThis study will examine the types of bacteria present in the dental plaque of patients with persistent dry mouth. Saliva is essential for digestion and swallowing and for maintaining the normal mineralization of teeth. People who suffer from dry mouth usually have a significant increase in tooth decay (caries). This study will determine if this increase is due solely to reduced salivary flow or also to an increase in certain types of bacteria in the mouth. Patients participating in the following NIDCR protocols may be eligible for this study: Evaluation and Treatment of Salivary Dysfunction (84-D-0056), Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome Research Project (99-D-0070), and Salivary Evaluation in Normal Volunteers (94-D-0018). Participants will have three appointments at the NIH dental clinic as follows: Visit 1 Dental examination and instruction on keeping a detailed diary of food intake. Visit 2 (1 week after visit 1) Attachment of a bacteria collection device (described below) to the side of a tooth. Visit 3 (48 hours after visit 2) Removal of the collection device, tooth cleaning and polishing, and submission of food diary. The bacteria collection device is a 4mm x 2mm x 2mm square of sterilized tooth obtained from slicing an extracted healthy tooth donated by another patient. The donated teeth are either extracted impacted third molars (wisdom teeth) or teeth extracted for teeth straightening (orthodontics). The device is heat-sterilized before being bonded to the participant's tooth. The dental cement used for bonding can be removed after 48 hours with no damage to the surface of the participant's tooth.
Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
PemphigoidBullous3 moreThe primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.
Collection of Blood, Bone Marrow, Leukapheresis, and Tissue Biopsy Samples From Patients and Their...
Idopathic Inflammatory/Autoimmune SyndromesBackground: - The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is conducting a variety of laboratory research experiments that require blood, bone marrow, urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic, autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated samples will be sent to the CHI laboratory at the National Institutes of Health to be used in research that may provide more information on the changes in the immune system caused by these specific disorders. Objectives: - To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue samples from patients with immune-mediated and inflammatory diseases, as well as from family members, for ongoing exploratory research studies. Eligibility: Individuals at least 2 years of age who have been diagnosed with an immune-mediated or inflammatory disease, or have signs or symptoms of an immune or inflammatory disease without a formal diagnosis. Immediate family members (parent, child, sibling, grandchild) of the above mentioned individuals. Design: Participants will be screened with a complete medical history, physical examination, and blood and urine samples. Participants will provide blood, urine, stool, cheek swab, and tissue samples as required by the study researchers. Participants who have immune or inflammatory diseases will also provide blood and bone marrow samples collected through biopsies and leukapheresis (to collect specific blood cells). Adult relatives will provide additional samples through more invasive procedures such as leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of age) will not undergo these invasive procedures. No treatment will be provided as part of this protocol.
T and B Cell Responses in Autoimmune Diseases
Type 1 Diabetes MellitusMultiple Sclerosis4 moreThe study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells.
Mental Health Consequences of COVID19 Infection in the French RMD Cohort
Covid19Systemic Autoimmune Disease2 morethis observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.