Skip to main content
Clinical Trials/NCT01402687
NCT01402687
Completed
Not Applicable

Single Nucleotide Polymorphism (SNP)-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants

Dana-Farber Cancer Institute1 site in 1 country181 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hodgkin's Lymphoma
Sponsor
Dana-Farber Cancer Institute
Enrollment
181
Locations
1
Primary Endpoint
Develop and validate a clinically applicable SNP-based screening platform for mucositis risk
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Antin

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Have given informed consent to submit a sample of saliva for DNA isolation and SNP analysis
  • Have undergone autologous HSCT for treatment of Hodgkin's or non-Hodgkin's lymphoma or multiple myeloma at the Dana-Farber Cancer Institute from 1/1/2006 through 6/30/2010
  • Have medical records identifying whether the participants did or did not develop severe mucositis

Exclusion Criteria

  • Received Palifermin (Kepivance) prior to their conditioning regimen

Outcomes

Primary Outcomes

Develop and validate a clinically applicable SNP-based screening platform for mucositis risk

Time Frame: 2 years

Develop and validate a clinically applicable SNP-based screening platform that will define mucositis risk among patients undergoing conditioning regimens for HSCT

Study Sites (1)

Loading locations...

Similar Trials