LymphomaNCT00488553
Molecular Epidemiology of Lymphoma Patients
An observational study of Lymphoma, run by M.D. Anderson Cancer Center.
Trial summary
Primary Objectives: 1. To enroll and obtain, through questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic and behavioral profiles. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Apr 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in this study will include 400 with newly diagnosed lymphoma and 400 matched controls.
Who may be able to join
- Cases only: Newly diagnosed, previously untreated patients with lymphoma as the primary cancer.
- Age 18 years and older.
- Willing to donate 30ml of blood.
- Willing to complete a self-administered questionnaire.
- Controls only: No prior cancer.
Who cannot join
- Cases only: Prior history of cancer other than lymphoma.
- Unable to speak or read English
About this study
Primary Objectives:
- To enroll and obtain, through questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic and behavioral profiles.
- To assess the influence of relevant epidemiologic covariates such as age, gender, smoking and family history of cancer on the panel of susceptibility biomarkers.
- To evaluate the role of genomic instability in development of lymphomas.
Read the detailed description
This study will include individuals diagnosed with lymphoma and individuals with no history of cancer. Half of the participants in this study will have lymphoma, and half will have no history of cancer. Information from both groups will be compared to help researchers try to learn which factors may lead to the development of lymphoma.
If you agree to take part in this study, you will be asked to complete a questionnaire at M. D. Anderson. In this questionnaire, you will be asked about your demographics (such as your age, sex, etc.), certain environmental exposures (such as pollution), your medical history, family history, diet, and your past and present smoking and alcohol use habits. This questionnaire should take about 50 minutes to complete.
You will also have about 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors (such as changes in your DNA) that may be linked to lymphoma. You will not be informed of the results of any of the testing done with your blood samples.
Your participation will be over in this study once your blood has been drawn.
This is an investigational study. Up to 800 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lymphoma
- Being tested
- Questionnaire
- Keywords
- Lymphoma, Epidemiology, Lifestyle Factors, Questionnaire, Survey
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questions about cancer risk factors, medical history, and family history of cancer.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants of study with newly diagnosed lymphoma. Receives: Behavioral: Questionnaire | |
| Control | Participants of study from matched control group. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify biologic (such as genes) and lifestyle factors that may increase a person's risk of developing lymphoma.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startAug 2006
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: No participants recruited, study discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randa El-Zein, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488553
- Sponsor's protocol ID
- 2006-0281
- Status last verified
- Feb 2012
- First submitted
- 19 Jun 2007
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology of Lymphoma Patients
- ClinicalTrials.gov ID
- NCT00488553
- Acronym / sponsor ID
- 2006-0281
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Epidemiology, Lifestyle Factors, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants recruited, study discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Jun 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.
Primary Objectives:
- To enroll and obtain, through questionnaires, risk factor information on all study participants to develop detailed demographic, epidemiologic and behavioral profiles.
- To assess the influence of relevant epidemiologic covariates such as age, gender, smoking and family history of cancer on the panel of susceptibility biomarkers.
- To evaluate the role of genomic instability in development of lymphomas.
Detailed description
This study will include individuals diagnosed with lymphoma and individuals with no history of cancer. Half of the participants in this study will have lymphoma, and half will have no history of cancer. Information from both groups will be compared to help researchers try to learn which factors may lead to the development of lymphoma.
If you agree to take part in this study, you will be asked to complete a questionnaire at M. D. Anderson. In this questionnaire, you will be asked about your demographics (such as your age, sex, etc.), certain environmental exposures (such as pollution), your medical history, family history, diet, and your past and present smoking and alcohol use habits. This questionnaire should take about 50 minutes to complete.
You will also have about 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors (such as changes in your DNA) that may be linked to lymphoma. You will not be informed of the results of any of the testing done with your blood samples.
Your participation will be over in this study once your blood has been drawn.
This is an investigational study. Up to 800 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: QuestionnaireParticipants of study with newly diagnosed lymphoma. |
| Control | – | Behavioral: QuestionnaireParticipants of study from matched control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will include 400 with newly diagnosed lymphoma and 400 matched controls.
Key inclusion criteria (5 listed)
- Cases only: Newly diagnosed, previously untreated patients with lymphoma as the primary cancer.
- Age 18 years and older.
- Willing to donate 30ml of blood.
- Willing to complete a self-administered questionnaire.
- Controls only: No prior cancer.
Key exclusion criteria (2 listed)
- Cases only: Prior history of cancer other than lymphoma.
- Unable to speak or read English
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: SurveyQuestions about cancer risk factors, medical history, and family history of cancer. | Behavioural | Cases, Control |
Primary outcome
To identify biologic (such as genes) and lifestyle factors that may increase a person's risk of developing lymphoma.
Time frame: 4 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
- UT 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.
Randa El-Zein, MD, PhD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by M.D. Anderson Cancer Center.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To identify biologic (such as genes) and lifestyle factors that may increase a person's risk of developing lymphoma. (time frame: 4 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 24 Feb 2012.