Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders

Multiple Myeloma Clinical Trial

Official title:

Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00582621
• Other study ID #: 00-069
• Status: Recruiting
• Start date: July 2000
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kenneth Offit, MD
• Phone: 646-888-4050
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to better understand the genetic causes of Hodgkin's disease (a kind of lymphoma) and non-Hodgkin's lymphoma, as well as multiple myeloma, leukemia, and related diseases. The doctors have identified the patient because 1) they have had a lymphoproliferative disorder such as lymphoma, leukemia, or multiple myeloma, and have a family member with one of these disorders or 2) they are a member of a family with a lymphoproliferative disorder, including Hodgkin's disease and/or, non-Hodgkin's lymphoma or a second cancer after Hodgkin's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Individuals with a personal and/or family history of lymphoma or lymphoproliferative disease B-cell malignancies, or multiple myeloma referred for study participation, or MSK patients referred from to the MSKCC outpatient clinics of the Lymphoma, Multiple Myeloma, or Leukemia Services in the Department of Medicine in consultation for treatment who are found on routine history or through a Family History Questionnaire (FHQ) (Appendix A). Individuals who have relatives or members of successive generations of the family affected with Hodgkin's disease, non-Hodgkin's lymphoma, lymphoid leukemia, multiple myeloma other lymphoproliferative disease prostate or pancreatic cancers, or other conditions suggesting hereditary cancer at the discretion of the MSKCC Principal Investigator. Patients with lymphoma, associated with colon and renal cancer will be eligible for DNA storage through this protocol. Family members or probands with Hodgkin's disease who are women who received therapeutic irradiation for Hodgkin's disease" or who developed secondary cancers after Hodgkin's disease are also eligible for participation.

• The criteria for eligibility are broad because the ascertainment by the computerized FHQ does not allow for resolution of different types of lymphoma or different types of leukemia. Patient recall of this information is also imprecise. More accurate family history information will be obtained upon contact of family members and diagnoses will be verified by obtaining pathologic documentation. The spectrum of familial lymphoproliferative syndromes (LPS) may include all types of lymphoma as well as chronic lymphocytic leukemia. This is an additional reason to have a broad eligibility. Subset analysis will be performed on specific types of lymphoid neoplasms. DNA of patients with a family history of lymphoma who have consented to protocol 93-102 ("Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers") will also be eligible for inclusion in this study.

• Family members of probands including patients, sisters, brothers, halfbrothers and sisters, sons, daughters, grandparents, as well as aunts and uncles are also eligible. An effort will be made to ascertain all living affected and unaffected living relatives in the affected lineage. An emphasis will be on affected sibling pairs and both parents, if alive.

• As this study involves research that presents no greater than minimal risk to children (see Sec. 46.404 of Federal Regulations part 46), minors are also eligible for participation. The assent of any minor should be obtained before the patient is enrolled into this study, as well as the consent of the legal guardian.

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Colon Cancer
• Kidney Neoplasms
• Leukemia
• Lymphoma
• Lymphoproliferative Disorders
• Multiple Myeloma
• Renal Cancer

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville	Rockville Centre	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Montefiore Medical Center, St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish a collection of DNA and frozen lymphocytes for the purpose of facilitating genetic laboratory investigations of familial lymphoid neoplasms.		2 years
Secondary	To perform linkage and candidate gene studies on informative families for the purpose of identifying novel lymphoproliferative syndrome (LPS) predisposition genes.		2 years

External Links

•   Memorial Sloan Kettering Cancer Center