LeukemiaNCT00503256
Genetic Study of Chronic Lymphocytic Leukemia Families
An observational study of Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Leukemia
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with chronic lymphocytic leukemia (CLL) and their living unaffected or affected relatives.
Who may be able to join
- 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.
Who cannot join
- 1) No exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research is to identify genes that may be related to the risk of developing CLL.
Objectives:
Read more
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.
Read the detailed description
This study does not involve taking any medications.
You will be asked to provide study personnel with authorization to request medical records from your physician, the hospital, and/or from other health care facilities where you were diagnosed with cancer. The information gathered will be used to help verify the diagnosis. Study personnel may also need to contact you in the future by phone, mail, or e-mail in order to ask questions about the status of your health.
For this research study, you will be asked to have around 4 tablespoons of blood drawn from a vein in your arm or you will also be asked to provide a sample of cheek cells by spitting into a collection container. The blood and cheek cell samples will be used for special tests to look for genes that may play a role in the development of CLL. You will also be asked to complete a family history questionnaire and a risk factor questionnaire. The family history questionnaire and the risk factor questionnaire will each take 60 minutes to complete. You will need to contact your family members before you send the completed family history questionnaire back to the study staff. You must ask for their permission to send the study staff their contact information. Family members with CLL or other leukemias or lymphomas, as well as a sample of your unaffected family members, will then be contacted by study personnel about participating in the study.
If you live in Houston, or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.
All blood and cheek cells collected will only be used by researchers involved in this study. Genetic information from the analysis of your blood and cheek cells will be included in a repository of genetic information at the National Institutes of Health, but no personal identifying information will be sent. All information will be kept confidential. Neither you nor your doctor will receive the results of these tests and they will NOT be put in your medical record.
This is an investigational study. Up to 450 participants will be enrolled by M. D. Anderson researchers. A total of 4000 participants will be enrolled in this multicenter study.
- Conditions
- Leukemia
- Being tested
- Questionnaire
- Keywords
- Chronic Lymphocytic Leukemia, Leukemia, Lymphoma, Questionnaire, Survey, CLL
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires each taking 60 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| CLL - Linkage Families | Gene identification related to Chronic lymphocytic leukemia (CLL) development Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL)
Measured: Data collection over 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startSep 2003
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Alessandra Ferrajoli, MD, BS, Principal investigator, M.D. Anderson Cancer CenterSusan Slager, Ph.D., Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503256
- Sponsor's protocol ID
- ID03-0117
- Status last verified
- May 2019
- First submitted
- 16 Jul 2007
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Study of Chronic Lymphocytic Leukemia Families
- ClinicalTrials.gov ID
- NCT00503256
- Acronym / sponsor ID
- ID03-0117
- Conditions
- Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Leukemia, Lymphoma, Questionnaire, Survey, CLL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Mayo Clinic
- Study start
- Sep 2003 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study does not involve taking any medications.
You will be asked to provide study personnel with authorization to request medical records from your physician, the hospital, and/or from other health care facilities where you were diagnosed with cancer. The information gathered will be used to help verify the diagnosis. Study personnel may also need to contact you in the future by phone, mail, or e-mail in order to ask questions about the status of your health.
For this research study, you will be asked to have around 4 tablespoons of blood drawn from a vein in your arm or you will also be asked to provide a sample of cheek cells by spitting into a collection container. The blood and cheek cell samples will be used for special tests to look for genes that may play a role in the development of CLL. You will also be asked to complete a family history questionnaire and a risk factor questionnaire. The family history questionnaire and the risk factor questionnaire will each take 60 minutes to complete. You will need to contact your family members before you send the completed family history questionnaire back to the study staff. You must ask for their permission to send the study staff their contact information. Family members with CLL or other leukemias or lymphomas, as well as a sample of your unaffected family members, will then be contacted by study personnel about participating in the study.
If you live in Houston, or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.
All blood and cheek cells collected will only be used by researchers involved in this study. Genetic information from the analysis of your blood and cheek cells will be included in a repository of genetic information at the National Institutes of Health, but no personal identifying information will be sent. All information will be kept confidential. Neither you nor your doctor will receive the results of these tests and they will NOT be put in your medical record.
This is an investigational study. Up to 450 participants will be enrolled by M. D. Anderson researchers. A total of 4000 participants will be enrolled in this multicenter study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLL - Linkage Families | – | Behavioral: QuestionnaireGene identification related to Chronic lymphocytic leukemia (CLL) development |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with chronic lymphocytic leukemia (CLL) and their living unaffected or affected relatives.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires each taking 60 minutes to complete. | Behavioural | CLL - Linkage Families |
Primary outcome
Candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL)
Time frame: Data collection over 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Ferrajoli, MD, BS principal investigator
M.D. Anderson Cancer Center
Susan Slager, Ph.D. study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL) (time frame: Data collection over 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.