- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582621
Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
January 19, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kenneth Offit, MD
- Phone Number: 646-888-4050
Study Contact Backup
- Name: Gilles Salles, MD, PhD
- Phone Number: 646-608-2642
- Email: SallesG@mskcc.org
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge
-
Contact:
- Kenneth Offit, MD, MPH
- Phone Number: 646-888-4050
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth
-
Contact:
- Kenneth Offit, MD, MPH
- Phone Number: 646-888-4050
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Contact:
- Kenneth Offit, MD, MPH
- Phone Number: 646-888-4050
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Contact:
- Kenneth Offit, MD, MPH
- Phone Number: 646-888-4050
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Kenneth Offit, MD, MPH
- Phone Number: 646-888-4050
-
Rockville Centre, New York, United States, 11570
- Recruiting
- Memorial Sloan Kettering Rockville
-
Contact:
- Kenneth Offit, MD, MPH
- Phone Number: 646-888-4050
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kenneth Offit, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2000
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimated)
December 28, 2007
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Multiple Myeloma
- Lymphoproliferative Disorders
Other Study ID Numbers
- 00-069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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