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Trial record 1 of 1 for:    Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies | Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies
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Establishing a Tumor Bank in Families With Multiple Lymphoproliferative Malignancies

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ClinicalTrials.gov Identifier: NCT00131014
Recruitment Status : Recruiting
First Posted : August 17, 2005
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date August 15, 2005
First Posted Date August 17, 2005
Last Update Posted Date May 30, 2019
Study Start Date August 2004
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2018)
Genetic factors that contribute to the development of lymphomas and CLL [ Time Frame: Indefinite ]
Genetic factors that contribute to the development of lymphomas and CLL
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Brief Summary 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.
Detailed Description
  • 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.
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood Cheek cells Paraffin blocks of tumor tissue
Sampling Method Non-Probability Sample
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
Condition
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Leukemia, Lymphocytic, Chronic
  • Lymphoproliferative Disorders
Intervention Not Provided
Study Groups/Cohorts
  • Next of Kin of deceased subj by lymphoma
    Next of Kin of deceased subject by lymphoma
  • Subject unaffected by lymphoma
    Subject unaffected by lymphoma
  • Subject affected by lymphoma
    Subject affected by lymphoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 10, 2009)
1500
Original Enrollment
 (submitted: August 16, 2005)
475
Estimated Study Completion Date January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Conner Shaughnessy 617-582-8437 Conner_Shaughnessy@DFCI.HARVARD.EDU
Contact: Jennifer Brown, MD PhD 617-632-4564 Jennifer_Brown@dfci.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00131014
Other Study ID Numbers 04-165
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators Not Provided
Investigators
Principal Investigator: Jennifer R. Brown, MD, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date May 2019