Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Montefiore Medical Center
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582621
First received: December 21, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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
Lymphoma
Leukemia
Multiple Myeloma
Colon Cancer
Renal Cancer

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood or alternatively, subjects may provide a saliva or buccal cell sample


Estimated Enrollment: 500
Study Start Date: July 2000
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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 or Leukemia Services in the Department of Medicine.

Criteria

Inclusion Criteria:

  • Patients with lymphoma or lymphoproliferative disease accepted for referral to the Cancer Family Clinic of the Department of Human Genetics for genetic counseling, or to the MSKCC outpatient clinics of the Lymphoma 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) to have relatives or members of successive generations of the family affected with Hodgkin's disease, non-Hodgkin's lymphoma, lymphoid leukemia, multiple myeloma or other lymphoproliferative disease. 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.
  • Also eligible for inclusion are up to 2000 anonymized familial lymphoma/leukemia samples from Montefiore Medical Center, with information on age of onset, gender, lymphoma or leukemia type, familial relationship, and year of sample collection. No PHI will be used and therefore these samples will be fully and permanently anonymized to MSKCC.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582621

Contacts
Contact: Kenneth Offit, MD 646-888-4050

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Montefiore Medical Center
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Kenneth Offit, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582621     History of Changes
Other Study ID Numbers: 00-069
Study First Received: December 21, 2007
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Colonic Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Leukemia
Lymphoma
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders

ClinicalTrials.gov processed this record on August 19, 2014