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Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders

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ClinicalTrials.gov Identifier: NCT00582621
Recruitment Status : Recruiting
First Posted : December 28, 2007
Last Update Posted : April 25, 2018
Sponsor:
Collaborators:
Montefiore Medical Center
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease
Lymphoma Leukemia Multiple Myeloma Colon Cancer Renal Cancer

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
Study Start Date : July 2000
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018





Primary Outcome Measures :
  1. To establish a collection of DNA and frozen lymphocytes for the purpose of facilitating genetic laboratory investigations of familial lymphoid neoplasms. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To perform linkage and candidate gene studies on informative families for the purpose of identifying novel lymphoproliferative syndrome (LPS) predisposition genes. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood or alternatively, subjects may provide a saliva or buccal cell sample


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinical Genetics Service at MSKCC or to the MSKCC outpatient clinics of the Lymphoma, Multiple Myeloma or Leukemia Services in the Department of Medicine.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582621


Contacts
Contact: Kenneth Offit, MD 646-888-4050
Contact: Andrew D Zelenetz, MD, PhD 212-639-2656

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Kenneth Offit, MD, MPH    646-888-4050      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Kenneth Offit, MD, MPH    646-888-4050      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Kenneth Offit, MD, MPH    646-888-4050      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kenneth Offit, MD, MPH    646-888-4050      
Memorial Sloan Kettering @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Kenneth Offit, MD, MPH    646-888-4050      
Memoral Sloan Kettering Cancer Center at Phelps Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Kenneth Offit, MD, MPH    646-888-4050      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Montefiore Medical Center
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Kenneth Offit, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582621     History of Changes
Other Study ID Numbers: 00-069
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Genetic Studies
00-069
blood
saliva
buccal cell

Additional relevant MeSH terms:
Multiple Myeloma
Lymphoproliferative Disorders
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial