Risk Factors for Non-HIV-Related Kaposi s Sarcoma
Kaposi's SarcomaThis study will try to identify risk factors for Kaposi s sarcoma, a rare skin cancer, and to understand the role of the KSHV virus in development of the disease. All native-born Italians 21 years of age or older residing in Sicily from July 1, 2002 through June 30, 2005 who have Kaposi s sarcoma not related to HIV infection may be eligible for this study. Healthy control subjects will also be enrolled. All participants will be interviewed about their childhood, jobs, habits, medical conditions, and treatments. They also will provide a blood sample and a saliva sample, obtained by swishing a mouthwash for 45 seconds and spitting it into a container. Blood will be tested for two viruses KSHV and HIV that are related to Kapsosi s sarcoma. The KSHV virus is newly discovered and not well understood. In general, a positive KSHV test probably means an infection with the virus has occurred in the past, but not necessarily that disease has developed. HIV is the virus that causes AIDS. People with AIDS have a high risk of Kapsosi s sarcoma. Although HIV and AIDS are very rare among older adults in Sicily, the presence of HIV must be ruled out in order to understand how KSHV is related to Kapsosi s sarcoma. The blood may also be used to measure immunity (the body s defense against infection and cancer) and for genetic studies to help discover why Kapsosi s sarcoma occurs.
Studies of Human Herpesvirus 8 and Kaposi's Sarcoma in Sicily
Kaposi s Sarcoma (KS)A series of studies will be conducted in Sicily by a collaborative team from the U.S. National Cancer Institute and the University of Palermo to better understand the prevalence and risk factors for the newly discovered human herpes virus 8 (HHV8) and Kaposi s sarcoma (KS), which may be a consequence of HHV8 infection. There are four short-term projects: To determine HHV8 seroprevalence in extant, unlinked sera from informative groups, including homosexual men, persons with sexually transmitted diseases, and in general population groups, particularly the elderly. In addition, HHV8 prevalence and other serological studies may be determined among other adults, particularly those who may be recruited for future studies and those likely to enhance understanding of HHV8 serology. To identify a pediatric syndrome that might be associated with HHV8 infection, HHV8 seroprevalence will be determined in sera from hospitalized children with a wide range of clinical conditions. To determine HHV8 seroprevalence in various regions of Italy and by HLA Class II groups that have been linked to increased (HLA-DR5) or decreased (HLA-DR3) risk of KS, using extant, unlinked sera and data from volunteer bone marrow donors. To conduct a case control study that will identify risk factors for KS among persons who are infected with HHV8 and who manifest anti-HHV8 latent antibodies. The results of these projects will be summarized for publication in the medical and scientific literature and for the design and prioritization of related projects in the future.
Collection of Alveolar Soft Part Sarcoma and Blood Specimens for Research
Alveolar Soft Part SarcomaSarcomaBackground: Alveolar soft part sarcoma (ASPS) is a rare tumor. ASPS is resistant to chemotherapy and radiation. ASPS is characterized by slow growth. Currently no in vitro or in vivo models of ASPS exist for use in experimental therapeutic studies or biological investigations. Primary Objectives: Acquisition of blood and tissue from patients with ASPS. Acquisition of blood from healthy controls for comparison with blood from patients with ASPS. These control samples will be obtained from study NCI at Frederick Protocol OH99-C-N046. Eligibility: Subjects of any age with a diagnosis of primary or metastatic alveolar soft part sarcoma who are undergoing medically indicated surgery for their disease. Design: Patients with Alveolar Soft Part Sarcoma (ASPS) will be eligible for this study. Biopsy tissue will be obtained as an additional sample at the time of a medically indicated procedure. Blood sample may be collected at initial visit and follow-up visits. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and/or stored for use in research efforts in the laboratory of Dr. David Vistica, National Cancer Institute, Frederick, MD. Additionally, blood samples will be obtained from healthy volunteers for comparison to patients with ASPS. These control samples will be obtained from the National Cancer Institute at Frederick Protocol OH99-C-N046.
Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated...
Acquired Immunodeficiency SyndromeKaposi's Sarcoma4 moreThis protocol presents the rationale, 25-year historical review, and methods for multidisciplinary, low-risk studies of individuals referred to the NCI Viral Epidemiology Branch (VEB). Referrals are generally for unusual types of cancer or related conditions, known, or suspected to be related to viruses. Kaposi's sarcoma in two homosexual men evaluated in 1981 is a classic example. These referral cases provide the basis for pilot studies that generate hypotheses, the development of protocols for formal investigations of promising leads, and help to set priorities for VEB. A VEB investigator who is a Staff Member at the NIH Clinical Center, interviews each subject, performs a physical examination, draws a blood sample, and, when appropriate for the disease or virus under study, obtains other clinically indicated biological specimens, such as urine, sputum, saliva, tears, semen, Pap smear, or cervical, anal, oral, or nasal swabs. On occasion, other relatively non-invasive studies may be indicated. Skin testing with conventional, licensed antigens for assessment of cellular immunity may be performed, and skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons. Otherwise no surgery is performed, and no therapy is administered. Clinical referral to other components of NCI, NIH, or the private sector are made as needed. The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed. Such laboratory testing is performed either at VEB's own support laboratory, or collaboratively in other NCI, NIH, or extramural laboratories that have the needed expertise for the disease or virus under study. Occasionally, repeated or more long-term evaluation is required. More often, a single evaluation in the NIH outpatient clinic, or either at a collaborating physician's office or other suitable site in the field, is sufficient. The VEB investigator provides counseling relevant to the virus or disease under study, and about the interim study results. He or she makes appropriate referral if needed (e.g., to the Genetic Epidemiology Branch for genetic counseling). Clinically relevant results and the VEB investigator's interpretation of these results, are provided in writing to the subject's primary caregiver. Confidentially of the information that is obtained is carefully protected. The results of the study are summarized for publication in the peer review literature.
Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer, Osteosarcoma, Soft Tissue Sarcoma...
Pancreatic CancerOsteosarcoma6 moreForty patients with advanced pancreatic cancer, osteosarcoma, soft tissue sarcoma, and breast cancer will receive DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one to three times a week. DeltaRex-G may or may not be given with one or more FDA approved cancer therapies/immunotherapies. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.
Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment...
Advanced Soft-tissue SarcomaMetastatic Soft-tissue SarcomaThe aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide. Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
Burden and Medical Care of Sarcoma in Germany
SarcomaThe main objective of the study is to assess the treatment situation of sarcoma patients in Germany and to investigate their potential influence on Quality of Life (and other Patient Reported Outcomes) of the affected persons. Impaired quality of life domains and factors associated with it are to be identified. To this end, a national network of sarcoma treatment specialists and a structure for patient recruitment will be established. This care network is intended to reflect the current situation of the treatment of sarcoma patients in Germany.
Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas
Soft Tissue SarcomaThis clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung...
Soft Tissue SarcomaMetastatic Lung DiseaseThe purpose of this study is to evaluate the role of palliative surgery in improving Quality of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS) and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for resection of the primary tumour will be compared to those that are unable to have surgery. Data collected from this questionnaire can highlight the benefits in patients' QoL who receive palliative surgical resection, and whether these benefits surmount those who are not treated with palliative surgery.
Biomarkers in Patients With Advanced Rhabdomyosarcoma
Adult RhabdomyosarcomaChildhood Alveolar Rhabdomyosarcoma6 moreThis research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.