Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies - Full Text View

Sponsored by:	Dana-Farber Cancer Institute
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00131014

Purpose

The purpose of this study is to investigate possible genetic factors that contribute to the development of lymphomas. The databank will be used to determine whether familial lymphomas have unique genetic characteristics different from sporadic lymphomas and to attempt to identify a gene that confers an increased risk of lymphoma.

Condition
Non-Hodgkin's Lymphoma Hodgkin's Disease Leukemia, Lymphocytic, Chronic Lymphoproliferative Disorders

MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Family-Based, Prospective
Official Title:	Establishing a Tumor Bank and Initial Analysis of Germline and Tumor-Related Genetic Alterations in Families With Multiple Lymphoproliferative Malignancies

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood Cheek cells Paraffin blocks of tumor tissue

Estimated Enrollment:	600
Study Start Date:	August 2004
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Next of Kin of deceased subject by lymphoma
2 Subject unaffected by lymphoma
3 Subject affected by lymphoma

Detailed Description:

Patients who participate will be asked to complete detailed family and medical history questionnaires initially, with a follow-up questionnaire every year.
Patients will be asked to supply a blood sample and possibly a mouthwash sample, both of which can be done by mail.
Patients will be asked to consent to the release of their lymphoma tissue block for the purposes of the study.
Patients will be given letters of invitation for their affected relatives to invite them to participate.

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

Group 1: Next of kin of a relative who has died from lymphoma Group 2: Subjects who have a next of kin diagnosed with lymphoma and/or CLL Group 3: Subjects who have had or have non-Hodgkin's lymphoma, CLL or Hodgkin's disease and had a relative who also had lymphoma or CLL

Criteria

Inclusion Criteria:

Any individual diagnosed with non-Hodgkin's lymphoma or Hodgkin's disease or chronic lymphocytic leukemia (CLL), who has a 1st degree relative (parent, sibling or child) with a lymphoproliferative disorder; or families in which the individual has a lymphoproliferative disorder, and an unusual clustering of frequent or premature solid tumors is also observed.
Family members of the individual, either affected or unaffected with lymphoma, who are contacted by the individual and agree to participate in the study.
Deceased family members may be included in the study. Public records such as death certificates may be used to confirm the history. Consent for medical records or tissue blocks will be obtained from the deceased family member's next of kin. The hierarchy of relatives defined as next of kin is spouse, offspring, parents and siblings. Archived tissue samples may be used for genetic research.
Age > 18 years

Exclusion Criteria:

Subjects without a family history of lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131014

Contacts

Contact: Jennifer R. Brown, MD, PhD	617-632-6692	jennifer_brown@dfci.harvard.edu
Contact: Megan Ash	617-582-8363	megan_ash@dfci.harvard.edu

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer R. Brown, MD, PhD 617-632-6692 jennifer_brown@dfci.harvard.edu
Contact: Megan Ash 617-582-8363 megan_ash@dfci.harvard.edu
Principal Investigator: Jennifer R. Brown, MD, PhD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

Principal Investigator:

Jennifer R. Brown, MD, PhD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Jennifer R. Brown, MD, PhD )
Study ID Numbers:	04-165
Study First Received:	August 15, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00131014
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Non-Hodgkin's Lymphoma
Hodgkin's disease
Chronic Lymphocytic Leukemia
Lymphoproliferative disorder
Genetics

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Leukemia, B-cell, chronic
Lymphoma, small cleaved-cell, diffuse
Leukemia

Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009