NCT00503256

Brief Summary

The goal of this research is to identify genes that may be related to the risk of developing CLL. Objectives: The objective of this study to investigate possible candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL) by identifying and recruiting high-risk families. Through our ongoing study of familial aggregation in CLL kindreds (protocol 2003-0498 'Genetic Study of Chronic Lymphocytic Leukemia'), we have identified CLL patients who have one or more living or dead relative(s) affected with CLL or other leukemias or lymphomas. We will also identify patients in high-risk families from referrals from leukemia clinicians and from self-referrals from patients who learn about our study from the ClinicalTrials.gov website. We plan to invite probands (patients diagnosed with CLL) and their family members with other leukemias and lymphomas and a sample of unaffected relatives to participate in a genetic/linkage study. We will obtain demographic and clinical information along with specimens (blood or buccal samples) from all participants. These families will be part of the Genetic Epidemiology of CLL Consortium, a multicenter, multidisciplinary consortium, based at the Mayo Clinic Cancer Center under the direction of Susan Slager, PhD. This is funded from NCI through a subcontract with Mayo Clinic. Genotypic data will be analyzed at Mayo Clinic, and coded, de-identified data will be shared with the NIH Genome-Wide Association Studies (GWAS) data repository.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

16 years

First QC Date

July 16, 2007

Last Update Submit

May 8, 2019

Conditions

Leukemia

Keywords

Chronic Lymphocytic LeukemiaLeukemiaLymphomaQuestionnaireSurveyCLL

Outcome Measures

Primary Outcomes (1)

  • Candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL)

    Data collection over 6 years

Study Arms (1)

CLL - Linkage Families

Gene identification related to Chronic lymphocytic leukemia (CLL) development

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaires each taking 60 minutes to complete.

Also known as: Survey
CLL - Linkage Families

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with chronic lymphocytic leukemia (CLL) and their living unaffected or affected relatives.

You may qualify if:

  • Patients with histologically confirmed CLL who have living or dead relatives affected with CLL. They must agree to complete a risk factor questionnaire and a family history questionnaire, and to donate a 50mL blood specimen or a buccal specimen.
  • Relatives of the CLL patients who have CLL or other lymphoproliferative disorders (i.e., leukemia \& lymphoma). They must agree to complete a risk factor questionnaire and donate a 50mL blood specimen or a buccal specimen. They will need to sign an authorization to release their medical records so that we can confirm their diagnosis.
  • A sample of unaffected relatives of the CLL patients. They must agree to complete a risk factor questionnaire and donate a 50mL blood specimen or a buccal specimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cheek cell sample collection that will be used for special tests to look for genes that may play a role in the development of CLL.

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alessandra Ferrajoli, MD, BS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

  • Susan Slager, Ph.D.

    Mayo Clinic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

September 1, 2003

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

US(1)