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

July 15, 2013 updated by: Joseph Antin, Dana-Farber Cancer Institute

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

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02214
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have undergone autologous HSCT for Hodgkin's or non-Hodgkin's lymphoma or multiple myeloma at Dana Farber Cancer Institute from 1/1/2006 through 6/30/2010.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mucositis Positive
Participants who developed severe mucositis
Mucositis Negative
Participants who did not develop severe mucositis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe