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

NCT01402687 | Completed DMC

• 1 other identifier: 10-236
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stem Cell Transplant; Mucositis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mucositis Positive

Participants who developed severe mucositis

Mucositis Negative

Participants who did not develop severe mucositis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Received Palifermin (Kepivance) prior to their conditioning regimen

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02214, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sample

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Multiple Myeloma; Mucositis

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Joseph Antin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2013-06

Locations

US (1)