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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01402687

Collaborator

(none)

181

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Multiple Myeloma

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.

Study Design

Study Type:

Observational

Actual Enrollment :

181 participants

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Mucositis Positive Participants who developed severe mucositis
Mucositis Negative Participants who did not develop severe mucositis

Outcome Measures

Primary Outcome Measures

Develop and validate a clinically applicable SNP-based screening platform for mucositis risk [2 years]
Develop and validate a clinically applicable SNP-based screening platform that will define mucositis risk among patients undergoing conditioning regimens for HSCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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