| Principal Investigator: | Hannon, Judith L (5) |
| Licence Number: | 14106 |
| Organization: | Canadian Blood Services |
| Licensed Year(s): |
2014
2013
2012
2011
2006
|
| Issued: | Feb 06, 2007 |
| Project Team: | Gwen Clarke, Greg Denomme, Willy A. Flegel, Jean ashdown, Gerri Barr, Bing Guthrie |
Objective(s): To confirm that the RhD phenotype is appropriately assigned in a population of prenatal patients that has not been studied for the presence of variant RhD gene alleles.
Project Description: Variation of RhD alleles as expressed among various ethnic populations has been much studied previously, and over 150 RhD alleles have been characterized at the DNA level. Some of these RhD alleles are so different from the wild type that persons possessing these alleles are at risk of making anti-D. Little is known about the RhD alleles among the indigenous populations in northern Canada. Prenatal testing is routinely performed to determine eligibility for Rh immune globulin; therefore, it is critical that the RhD status of all prenatal patients is correct. This study is designed to perform serological and genetic analyses of the phenotypic and genotypic composition of RhD alleles among northern aboriginal Canadians. Blood samples collected for routine prenatal screening at health centres, hospital and clinic laboratories throughout the Northwest Territories will be sent for analysis to the Prenatal Lab Edmonton Ctr for analysis. Informed consent will be obtained from all participating prenatal patients. For general statistical purposes, the Principal Investigator or her clinical delegate will record and be the only ones with access to the following information: 1) Patient’s name; 2) Date of birth; 3) Date of the sample; 4) Fetal gestational age; 5) Collection site; 6) Result of the antibody screen. No patient information will be linked to the study data; hence, once the routine clinical work is done, an anonymous number will be assigned to each sample. The patient’s identification label will be removed and the sample labelled with the study number, e.g. RHD0001. Access to the code book that links the study number to the serological/demographic information will be restricted to only the Principal Investigator and her clinical delegate. One hundred and twenty consecutive prenatal samples (representing both Rh positive and Rh negative) will be shipped to Dr. Willy Flegel in Ulm Germany for testing. The DNA sequences will be reviewed by Drs. Denomme and Flegel to identify novel alleles. The DNA and red cells from novel alleles will be returned to the Canadian Blood Services for archiving. All DNA and red cells will be destroyed within two years of sample collection. Left over blood from the Prenatal Lab Edmonton Ctr will be used for the DNA analysis after the routine clinical serological analyses and reports have been completed. There will be a process to report to and discuss with the patient the implications of the study results. Blood sampling will be conducted from February 6 to December 31, 2007 at health centres, hospitals and clinical laboratories in the following municipalities: Yellowknife, Hay River, Fort Simpson, Fort Smith, Inuvik, Fort Providence, Fort Resolution, Fort Liard, Lutsel K'e, Rae Edzo, Whati, Wekweti, Rae Lakes, Fort Wrigley, Tulita, Norman Wells, Fort Good Hope, Fort McPherson, Aklavik, Tuktoyaktuk, Paulatuk, Holman, and Sachs Harbour.
