SNP-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants (HSCT)
The goal of this study is to gain new knowledge about genetic risk factors thta may affect the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus following HSCT. The study seeks to understand if different forms of genes result in an increased risk of sores in the mouth and esophagus.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Single Nucleotide Polymorphism (SNP)-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants|
- Develop and validate a clinically applicable SNP-based screening platform for mucositis risk [ Time Frame: 2 years ] [ Designated as safety issue: No ]Develop and validate a clinically applicable SNP-based screening platform that will define mucositis risk among patients undergoing conditioning regimens for HSCT
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Participants who developed severe mucositis
Participants who did not develop severe mucositis
Subjects will be provided with a saliva collection kit which can be used at home. Subjects will return the collection kit in a paid, pre-addressed mailer to the laboratory at Biomodels. The laboratory will isolate and store the DNA located in the cells of the saliva. A portion of this DNA will be used to analyze the different forms of genes. The remainder of the DNA will be destroyed when this study is completed. Biomodels will not be provided with patient identifiers.
The investigators will also collect information from medical records, including information about diagnosis, treatment, stem cell transplantation and post-transplantation outcomes. This information will be de-identified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402687
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Joseph Antin, MD||Dana-Farber Cancer Institute|