Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies
This study is currently recruiting participants.
Verified May 2013 by Dana-Farber Cancer Institute
Sponsor:
Dana-Farber Cancer Institute
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: May 21, 2013
Last verified: May 2013
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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 |
|---|
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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
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: | May 21, 2013 |
| 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 June 13, 2013