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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Antin, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01402687
First received: July 25, 2011
Last updated: July 15, 2013
Last verified: June 2013
  Purpose

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
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Multiple Myeloma

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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

Saliva sample


Enrollment: 181
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mucositis Positive
Participants who developed severe mucositis
Mucositis Negative
Participants who did not develop severe mucositis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402687

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Joseph Antin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Joseph Antin, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01402687     History of Changes
Other Study ID Numbers: 10-236
Study First Received: July 25, 2011
Last Updated: July 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Stem Cell Transplant
Mucositis

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Hodgkin Disease
Mucositis
Stomatitis
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 22, 2014