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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402687
• Other study ID #: 10-236
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: July 15, 2013
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Mucositis
• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Stomatitis

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop and validate a clinically applicable SNP-based screening platform for mucositis risk	Develop and validate a clinically applicable SNP-based screening platform that will define mucositis risk among patients undergoing conditioning regimens for HSCT	2 years	No