LeukemiaNCT00525746
Molecular Epidemiology of Therapy-related Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS)
An observational study of Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome after treatment for a previous cancer (treatment-related AML/MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2006to 31 Mar 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants, 18 years or older, with a confirmed diagnosis of AML or MDS (cases), or treated for a primary malignancy (controls).
Who may be able to join
- Age 18 years or older
- Willing and able to provide written informed consent and authorization
- Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview
- A histologically confirmed diagnosis of AML or MDS (cases only)
- A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)
- Enrolled in leukemia/MDS studies under protocol ID00-173 or ID03-0250 (cases only)
- Treated for a primary malignancy at MDACC (controls only)
- Matched to cases (2:1) by cases' prior malignancy(site, treatment (chemo and/or radiation), year of diagnosis (+/- 3 years)), age (+/- 5 years), sex, and ethnicity. (controls only)
Who cannot join
- Under 18 years of age
- History of second primary malignancy (controls only)
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
Official title: Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome
The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome after treatment for a previous cancer (treatment-related AML/MDS).
Read the detailed description
For this study, you will be asked to take part in a personal or mail interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. Treatment information from your medical records at M. D. Anderson will also be collected.
You will be asked to provide a saliva sample or have around 1 tablespoon of blood drawn for special tests. These tests will look for biologic factors associated with treatment-related AML/MDS.
Your participation in this study will be over once the interview has been completed and blood or saliva have been collected.
This is an investigational study. Up to 600 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia, Myelodysplastic Syndrome
- Being tested
- Interview
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Leukemia, MDS, AML, Malignancy, Molecular Epidemiology, Epidemiologic markers, Clinical markers, Constitutional genetic markers, Case-comparison study
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Interview lasting about 50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a confirmed diagnosis of AML or MDS (cases). Receives: Behavioral: Interview | |
| Controls | Patients treated for a primary malignancy (controls). Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study start31 Mar 2006
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jian Gu, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525746
- Sponsor's protocol ID
- 2004-0490
- Status last verified
- Jan 2020
- First submitted
- 4 Sep 2007
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology of Treatment-Related Acute Myeloid Leukemia/Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00525746
- Acronym / sponsor ID
- 2004-0490
- Conditions
- Leukemia, Myelodysplastic Syndrome
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Leukemia, MDS, AML, Malignancy, Molecular Epidemiology, Epidemiologic markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Mar 2006 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Sep 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 study is to identify biologic and lifestyle factors that may increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome after treatment for a previous cancer (treatment-related AML/MDS).
Detailed description
For this study, you will be asked to take part in a personal or mail interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. Treatment information from your medical records at M. D. Anderson will also be collected.
You will be asked to provide a saliva sample or have around 1 tablespoon of blood drawn for special tests. These tests will look for biologic factors associated with treatment-related AML/MDS.
Your participation in this study will be over once the interview has been completed and blood or saliva have been collected.
This is an investigational study. Up to 600 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: InterviewPatients with a confirmed diagnosis of AML or MDS (cases). |
| Controls | – | Behavioral: InterviewPatients treated for a primary malignancy (controls). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants, 18 years or older, with a confirmed diagnosis of AML or MDS (cases), or treated for a primary malignancy (controls).
Key inclusion criteria (8 listed)
- Age 18 years or older
- Willing and able to provide written informed consent and authorization
- Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview
- A histologically confirmed diagnosis of AML or MDS (cases only)
- A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)
Key exclusion criteria (2 listed)
- Under 18 years of age
- History of second primary malignancy (controls only)
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 |
|---|---|---|
| InterviewInterview lasting about 50 minutes. | Behavioural | Cases, Controls |
Primary outcome
Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
Jian Gu, PhD principal investigator
M.D. Anderson Cancer Center
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 and Myelodysplastic Syndrome, 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 8 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. 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?
Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development (time frame: 3 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 14 Jan 2020.