Boston, Massachusetts 02115


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.


Study summary:

- 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.


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


Study is Available At:


Original ID:

04-165


NCT ID:

NCT00131014


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Dana-Farber Cancer Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

1500


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jennifer R. Brown, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
Primary Contact:Conner Shaughnessy
617-582-8437
Conner_Shaughnessy@DFCI.HARVARD.EDU
Backup Contact:Jennifer Brown, MD PhD
617-632-4564
Jennifer_Brown@dfci.harvard.edu

Study Dates

Start Date:August 2004
Completion Date:January 2023
Completion Type:Anticipated
Primary Completion Date:January 2023
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 29, 2019
First Received Date:August 15, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Genetic factors that contribute to the development of lymphomas and CLL
Time Frame:Indefinite
Safety Issues:False
Description:Genetic factors that contribute to the development of lymphomas and CLL

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Next of Kin of deceased subj by lymphoma
Description:Next of Kin of deceased subject by lymphoma
Study Arm Type:Other
Arm Name:Subject unaffected by lymphoma
Description:Subject unaffected by lymphoma
Study Arm Type:Other
Arm Name:Subject affected by lymphoma
Description:Subject affected by lymphoma

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Dana-Farber Cancer Institute

Samples and Retentions

Sample Retention:Samples With DNA
Description: Whole blood Cheek cells Paraffin blocks of tumor tissue
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
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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