Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies | Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies
Previous Study | Return to List | Next Study

Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00131014
Recruitment Status : Recruiting
First Posted : August 17, 2005
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Non-Hodgkin's Lymphoma Hodgkin's Disease Leukemia, Lymphocytic, Chronic Lymphoproliferative Disorders

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
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
Study Start Date : August 2004
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Next of Kin of deceased subj by lymphoma
Next of Kin of deceased subject by lymphoma
Subject unaffected by lymphoma
Subject unaffected by lymphoma
Subject affected by lymphoma
Subject affected by lymphoma


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Genetic factors that contribute to the development of lymphomas and CLL [ Time Frame: Indefinite ]
    Genetic factors that contribute to the development of lymphomas and CLL


Biospecimen Retention:   Samples With DNA
Whole blood Cheek cells Paraffin blocks of tumor tissue

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131014


Contacts
Layout table for location contacts
Contact: Conner Shaughnessy 617-582-8437 Conner_Shaughnessy@DFCI.HARVARD.EDU
Contact: Jennifer Brown, MD PhD 617-632-4564 Jennifer_Brown@dfci.harvard.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jennifer R. Brown, MD, PhD Dana-Farber Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jennifer R. Brown, MD, PhD, Assistant Professor of Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00131014    
Other Study ID Numbers: 04-165
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Keywords provided by Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute:
Non-Hodgkin's Lymphoma
Hodgkin's disease
Chronic Lymphocytic Leukemia
Lymphoproliferative disorder
Genetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphoma, Non-Hodgkin
Hodgkin Disease
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
 Lymphoma
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell