Acute Myeloid LeukemiaNCT00159003
Analysis of Genetic Factors Related to Predisposition and Prognosis of Hematological Malignancies in Israel
An observational study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by Deborah Rund at 1 site in Israel.
Trial summary
There are naturally occuring variations in the genetic makeup of all of us. Some of these variations may contribute to a change in susceptibility toward different diseases or change the prognosis. We are studying these genetic variations in patients with leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 1998to 1 Jul 2017
- 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: Patients admitted to Hadassah Hospital with AML or CLL.
Who may be able to join
- diagnosis of acute myeloid leukemia or chronic lymphocytic leukemia
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Analysis of Genetic Elements Which May Influence Predisposition and Prognosis of Hematological Malignancies in Different Ethnic Groups in Israel
There are naturally occuring variations in the genetic makeup of all of us. Some of these variations may contribute to a change in susceptibility toward different diseases or change the prognosis.
We are studying these genetic variations in patients with leukemia. The genes we are studying are those which influence detoxification of drugs and toxins.
Read the detailed description
We have prepared DNA on patients with leukemia (AML, CML and CLL) and we are studying the influence of polymorphisms in drug metabolism and disposition genes on predisposition and prognosis of these types of leukemia. The genes we are studying include: MDR1, CYP3A4, NQO1, NAT1/2, GST, hOCT. We plan to study other genes that may be contributory.
Study includes comparing the frequency of polymorphisms in these genes with the frequency in the general population and the study of DNA biding proteins which bind at the sites of these polymorphisms.
- Keywords
- drug metabolism and disposition enzymes
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start1 Jan 1998
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Rund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Rund, Hadassah Medical Organization
- Investigators
- Deborah G Rund, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159003
- Sponsor's protocol ID
- 132910-HMO-CTIL
- Status last verified
- Aug 2017
- First submitted
- 8 Sep 2005
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chanock S. Genetic variation and hematology: single-nucleotide polymorphisms, haplotypes, and complex disease. Semin Hematol. 2003 Oct;40(4):321-8. doi: 10.1016/s0037-1963(03)00198-7.
PubMed 14582082
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Genetic Elements Which May Influence Predisposition and Prognosis of Hematological Malignancies in Different Ethnic Groups in Israel
- ClinicalTrials.gov ID
- NCT00159003
- Acronym / sponsor ID
- 132910-HMO-CTIL
- Keywords
- drug metabolism and disposition enzymes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Deborah RundUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 12 Sep 2005 (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.
There are naturally occuring variations in the genetic makeup of all of us. Some of these variations may contribute to a change in susceptibility toward different diseases or change the prognosis.
We are studying these genetic variations in patients with leukemia. The genes we are studying are those which influence detoxification of drugs and toxins.
Detailed description
We have prepared DNA on patients with leukemia (AML, CML and CLL) and we are studying the influence of polymorphisms in drug metabolism and disposition genes on predisposition and prognosis of these types of leukemia. The genes we are studying include: MDR1, CYP3A4, NQO1, NAT1/2, GST, hOCT. We plan to study other genes that may be contributory.
Study includes comparing the frequency of polymorphisms in these genes with the frequency in the general population and the study of DNA biding proteins which bind at the sites of these polymorphisms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Hadassah Hospital with AML or CLL.
Key inclusion criteria (1 listed)
- diagnosis of acute myeloid leukemia or chronic lymphocytic leukemia
Key exclusion criteria (1 listed)
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 14582082Chanock S. Genetic variation and hematology: single-nucleotide polymorphisms, haplotypes, and complex disease. Semin Hematol. 2003 Oct;40(4):321-8. doi: 10.1016/s0037-1963(03)00198-7.
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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.
Deborah G Rund, MD principal investigator
Hadassah Medical Organization
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 Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by Deborah Rund at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 10 Aug 2017. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159003, which also lists 1 linked publication.
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 10 Aug 2017.