Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Establishing a Tumor Bank and Initial Analysis of Germline and Tumor-Related Genetic Alterations in Families With Multiple Lymphoproliferative Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00131014
• Other study ID #: 04-165
• Status: Recruiting
• Start date: August 9, 2004
• Est. completion date: January 2033

Study information

• Verified date: March 2024
• Source: Dana-Farber Cancer Institute
• Contact: Celeste Carey, MS
• Phone: 857-215-1646
• Email: celeste_carey[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: January 2033
• Est. primary completion date: January 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma, Non-Hodgkin
• Lymphoproliferative Disorders
• Non-Hodgkin's Lymphoma

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic factors that contribute to the development of lymphomas and CLL	Genetic factors that contribute to the development of lymphomas and CLL	Indefinite