Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00131014
First received: August 15, 2005
Last updated: April 22, 2014
Last verified: April 2014
  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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Genetic factors that contribute to the development of lymphomas and CLL [ Time Frame: Indefinite ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood Cheek cells Paraffin blocks of tumor tissue


Estimated Enrollment: 1500
Study Start Date: August 2004
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (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
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: NCT00131014

Contacts
Contact: Jennifer R. Brown, MD, PhD 617-632-6692 jennifer_brown@dfci.harvard.edu
Contact: Kevin Hoang 617-632-5259 kevin_hoang@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   
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

No publications provided

Responsible Party: Jennifer R. Brown, MD, PhD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00131014     History of Changes
Other Study ID Numbers: 04-165
Study First Received: August 15, 2005
Last Updated: April 22, 2014
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

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on July 24, 2014