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Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID Clinical research trials and Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID. Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID clinical trial. Participants oftentimes recieve the most expert healthcare available for their Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID  Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID
Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID
For Condition: Severe Combined Immunodeficiency
Status: Recruiting
Sponsor(s): National Human Genome Research Institute (NHGRI) ,
Synopsis: The purpose of this study is to learn what factors influence adolescent girls' decisions regarding testing for carrier status of X-Linked Severe Combined Immunodeficiency (XSCID). It will provide information about how healthy relatives feel about whether they could be XSCID carriers, whether carrier testing should be pursued, and, if so, at what age. Commonly known as "Bubble Boy Disease," XSCID is a rare, life-threatening immune system disorder that affects only males, but females who carry the gene mutation can pass the disease to their male children. Adolescent girls 13 to 17 years old who have a relative with XSCID and are known to be at risk for being carriers are eligible for this study. Participants will receive genetic counseling to help them decide if they want to be tested for the XSCID gene. Those who elect to be tested will provide a DNA sample from either a blood draw or brushing taken from inside the mouth. They will receive the test results from the same genetic counselor they spoke with before the testing. All participants will also talk with a psychologist over the phone once a year for 3 years to answer questions about how they are feeling and what they know about XSCID. They will be asked to discuss their decision and feelings about carrier testing.
Details: This protocol studies carrier testing decisions of female adolescents who have a male relative with X-linked severe combined immunodeficiency (XSCID). XSCID is a rare immunodeficiency that affects only males, although females carrying XSCID mutations can pass the disease to their male offspring. In previous generations infant boys with XSCID uniformly died, but medical interventions such as bone marrow transplantation and now gene therapy, have proven life-saving for many patients. XSCID was mapped in 1987, and the disease gene was identified in 1993; these advances made possible patient and carrier diagnosis, which have been available on a research basis for 10 years through IRB-approved protocols of Dr. Puck. A large sample of XSCID families enrolling in molecular diagnosis protocols participated in her psychological study of the impact on adult siblings of having a brother affected with XSCID (Protocol OH98-HG-N015, Perception of Carrier Status in Families with X-Linked Severe Combined Immunodeficiency, now complete and terminated). That study indicated strong interest on the part of at-risk females for carrier diagnosis before reaching the age of adulthood. The current protocol is a follow-up protocol that functions in concert with Protocol 95-HG-0066 (Genetic Analysis of Immune Disorders) to study the decision-making process and the impact of carrier testing in female adolescents from families with known XSCID mutations. With parental consent, carrier testing for girls from age 13 through age 17 will be discussed in a genetic counseling session. The 50% risk of being a carrier and the 50% chance of XSCID in male offspring of carriers will be explained. Possible psychological and other benefits and harms of testing will be aired. If elected by the girl, XSCID mutation testing will be performed by having her enroll in our genetic testing protocol 95-HG-0066. Follow-up interviews with all girls enrolled, both tested and not tested, will be conducted at 3 months and a year post encounter.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Only families who have solicited adolescent carrier testing will be considered. Mentally competent females from 13 through 17 years of age are eligible to enroll if they have had a relative with XSCID proven by consistent medical history and mutation detection in IL2RG. Enrollees must be able to communicate in English (if a Spanish-speaking interviewer with appropriate expertise in genetics and psychology is located, interview forms may be translated so that subjects who speak Spanish can be included). All ethnic groups are eligible.
Total Enrollment: 40
Location and Contact Information:
National Human Genome Research Institute (NHGRI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000223; 00-HG-0223
Study Start Date: September 26, 2000
Record last reviewed: September 3, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006335
Other Severe Combined Immunodeficiency Studies:
1. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
2. Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID
3. Pilot Study of Allogeneic Bone Marrow Transplantation Plus Cyclosporine and Mycophenolate Mofetil to Induce Mixed Hematopoietic Chimerism in Patients With Primary T-Cell Immunodeficiency Disorders
4. Stem Cell Gene Therapy to Treat X-Linked Severe Combined Immunodeficiency (XSCID)
5. Cord Blood Stem Cell Transplantation Study (COBLT)
Related Studies:
Other Severe Combined Immunodeficiency Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Influences on Female Adolescents' Decisions Regarding Testing for Carrier Status of XSCID
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