Clinical trial NCT00131014: Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies
Official title: Establishing a Tumor Bank and Initial Analysis of Germline and Tumor-Related Genetic Alterations in Families With Multiple Lymphoproliferative Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Hodgkin's Lymphoma
Hodgkin's Disease
Leukemia, Lymphocytic, Chronic
Lymphoproliferative Disorders
Keywords: Non-Hodgkin's Lymphoma
Hodgkin's disease
Chronic Lymphocytic Leukemia
Lymphoproliferative disorder
Genetics
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2005-08-17
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: Genetic factors that contribute to the development of lymphomas and CLL
timeFrame: Indefinite
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer R. Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: