Acute Lymphoblastic LeukemiaNCT00402090
DHPLC Determination of TPMT Polymorphisms.
An observational study of Acute Lymphoblastic Leukemia, run by National Institute of Cancerología at 1 site in Mexico.
Trial summary
TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2005to Nov 2006
- 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
Who may be able to join
- Healthy and patientes with acute lymphoblastic leukemia.
- Age: older than 18 years.
- Attend to the National Institute of Cancerologia
Who cannot join
- Foreign patients with an irregular attendance to the National Institute of Cancerologia
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Cancerologia
Mexico City, Mexico City, 14080
Myrna Candelaria, MD, (52)55-5628-04-79, myrnac@prodigy.net.mx
Myrna Candelaria, MD
About this study
Official title: Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.
TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.
Read the detailed description
Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia.
- To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity.
- Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age > 18 years, who attend to the National Institute of Cancerologia.
- Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up.
- Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- thiopurines, thiopurine methyl transferase, toxicity, pharmacogenomics
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startApr 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic 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
- Time perspective
- Other
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Investigators
- Myrna Candelaria, MD, Principal investigator, National Institute of Cancerologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402090
- Sponsor's protocol ID
- 005/007/ICI
- Other IDs
- CONACYT: Salud-2004-01-005
- Status last verified
- Nov 2006
- First submitted
- 17 Nov 2006
- Last updated
- 22 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.
- ClinicalTrials.gov ID
- NCT00402090
- Acronym / sponsor ID
- 005/007/ICI
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- thiopurines, thiopurine methyl transferase, toxicity, pharmacogenomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- Apr 2005
- Study completion
- Nov 2006
- First posted
- 22 Nov 2006 (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.
TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.
Detailed description
Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia.
- To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity.
- Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age > 18 years, who attend to the National Institute of Cancerologia.
- Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up.
- Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy and patientes with acute lymphoblastic leukemia.
- Age: older than 18 years.
- Attend to the National Institute of Cancerologia
Key exclusion criteria (1 listed)
- Foreign patients with an irregular attendance to the National Institute of Cancerologia
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2006.
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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.
Myrna Candelaria, MD principal investigator
National Institute of Cancerologia
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 Lymphoblastic Leukemia, run by National Institute of Cancerología at 1 site in Mexico.
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 22 Nov 2006. 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 Mexico. 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?
Contact Myrna Candelaria, MD ((52)55-56280479, myrnac@prodigy.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Nov 2006.