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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01402687
Other study ID # 10-236
Secondary ID
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


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
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