InfectionsNCT00597090
The Role of Genetic Polymorphisms in Innate Immune Response Genes in Susceptibility to Infections
An observational study of Infections, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms. The goals of this study are: 1. Find out if some people are more likely to get severe infections, than others. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jan 2011
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population for this study is composed of patients with leukemia. It is projected that the marginal probability of an allelic variant in the TLR and an infection is 0.12 and 0.30 respectively in this patient population.
Who may be able to join
- Subject must either:
- Have histologically confirmed acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), follicular or mantle cell lymphoma RA-EB, RAEB-T newly diagnosed at first or second remission AND are going to receive or have received myelosuppressive chemotherapy; OR
- Will receive or have received allogeneic HSCT for hematologic malignancy.
- Subject has signed informed consent before entering the study.
- Participation of children: For subjects under the age of 18, we will obtain the subject's and their parents' approval to enroll them.
Who cannot join
- Subject has been diagnosed with leukemia other than acute myeloid leukemia RA-EB or RAEB-T or acute lymphocytic.
- Subject is not going to receive chemotherapy or has not received chemotherapy.
- Subject will undergo/had undergone HSCT for disease other than hematologic malignancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms.
The goals of this study are:
- Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
- Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.
Read the detailed description
A small number of patients will develop severe infection after chemotherapy or after allogeneic bone marrow transplantation. The ability of patients with leukemia or bone marrow transplantation to fight infections is decreased. One reason is that chemotherapy transiently destroys the type of white blood cells called neutrophils. Neutrophils are the first line of defense of our body against infections. Bone marrow transplant patients may be receiving edications to prevent graft versus host disease. Such medications may decrease the ability of the body to fight infections.
People respond to infections in different ways. Some may be born with genes that make them more likely to get certain types of infections. Specific genes may affect the response to different microbes (pathogens). We want to find out which genes have normal changes in them and lead to different responses to infections. We also want to find out how the ability to fight infections is related to the way these genes work.
Responses to infection are controlled by our immune system. Changes in genes of the immune system that may alter control of infection may make people more susceptible to some types of lymphoma The goals of this study are:
- Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
- Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.
The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms.
To accomplish this, blood specimens from patients with acute myeloid leukemia, RAEB, RAEBT or acute lymphocytic leukemia, follicular or mantle cell lymphoma or recipients of allogeneic hematopoietic stem cell transplants (HSCT) will be collected. We will genotype the genes of innate immune receptors to identify genetic polymorphisms associated with higher frequency of invasive infections or susceptibility to lymphoma. All specimens will be processed in the Infectious Diseases Laboratory at MSKCC. RNA will be extracted from peripheral blood mononuclear cells (PBMCs). Genotyping will be done from genomic DNA or from cDNA generated from RNA by RT-PCR. Cell lines will be created from PBMCs and will be analyzed in functional assays for responses to bacterial and fungal products (cytokine secretion, upregulation of cell surface molecules). All patient samples including genomic DNA, RNA, cDNA and cell lines will be banked in the Infectious Disease laboratory at MSKCC.
In order to perform this study, patients diagnosed with acute leukemia will be asked to provide blood, and permission to review the medical charts. We will collect (removed prospectively) data regarding risk factors for infections, diagnosis of infections, response to treatment and outcome.
- Conditions
- Infections
- Keywords
- Infections, lymphoma
- Medical subject headings
- Infections, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk for developing infection or lymphoma due to allelic variation in genes of immune system that specialize in pathogen recognition compared to absence of allelic variation.
Measured: 6 years
Secondary outcomes (1)
Risk for developing infectns due to somatic mutatns/polymorphisms in genes involved in signaling pathways downstream of receptors of immune recognitn.Characterize in vitro diff in functional responses to pathogens among genetic variants.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startFeb 2003
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Genovefa Papanicolaou, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597090
- Sponsor's protocol ID
- 03-017
- Status last verified
- Jan 2011
- First submitted
- 8 Jan 2008
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Genetic Polymorphisms in Innate Immune Response Genes in Susceptibility to Infections
- ClinicalTrials.gov ID
- NCT00597090
- Acronym / sponsor ID
- 03-017
- Conditions
- Infections
- Keywords
- Infections, lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Jan 2008 (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 purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms.
The goals of this study are:
- Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
- Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.
Detailed description
A small number of patients will develop severe infection after chemotherapy or after allogeneic bone marrow transplantation. The ability of patients with leukemia or bone marrow transplantation to fight infections is decreased. One reason is that chemotherapy transiently destroys the type of white blood cells called neutrophils. Neutrophils are the first line of defense of our body against infections. Bone marrow transplant patients may be receiving edications to prevent graft versus host disease. Such medications may decrease the ability of the body to fight infections.
People respond to infections in different ways. Some may be born with genes that make them more likely to get certain types of infections. Specific genes may affect the response to different microbes (pathogens). We want to find out which genes have normal changes in them and lead to different responses to infections. We also want to find out how the ability to fight infections is related to the way these genes work.
Responses to infection are controlled by our immune system. Changes in genes of the immune system that may alter control of infection may make people more susceptible to some types of lymphoma The goals of this study are:
- Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
- Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.
The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms.
To accomplish this, blood specimens from patients with acute myeloid leukemia, RAEB, RAEBT or acute lymphocytic leukemia, follicular or mantle cell lymphoma or recipients of allogeneic hematopoietic stem cell transplants (HSCT) will be collected. We will genotype the genes of innate immune receptors to identify genetic polymorphisms associated with higher frequency of invasive infections or susceptibility to lymphoma. All specimens will be processed in the Infectious Diseases Laboratory at MSKCC. RNA will be extracted from peripheral blood mononuclear cells (PBMCs). Genotyping will be done from genomic DNA or from cDNA generated from RNA by RT-PCR. Cell lines will be created from PBMCs and will be analyzed in functional assays for responses to bacterial and fungal products (cytokine secretion, upregulation of cell surface molecules). All patient samples including genomic DNA, RNA, cDNA and cell lines will be banked in the Infectious Disease laboratory at MSKCC.
In order to perform this study, patients diagnosed with acute leukemia will be asked to provide blood, and permission to review the medical charts. We will collect (removed prospectively) data regarding risk factors for infections, diagnosis of infections, response to treatment and outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population for this study is composed of patients with leukemia. It is projected that the marginal probability of an allelic variant in the TLR and an infection is 0.12 and 0.30 respectively in this patient population.
Key inclusion criteria (5 listed)
- Subject must either:
- Subject has signed informed consent before entering the study.
- Participation of children: For subjects under the age of 18, we will obtain the subject's and their parents' approval to enroll them.
Key exclusion criteria (3 listed)
- Subject has been diagnosed with leukemia other than acute myeloid leukemia RA-EB or RAEB-T or acute lymphocytic.
- Subject is not going to receive chemotherapy or has not received chemotherapy.
- Subject will undergo/had undergone HSCT for disease other than hematologic malignancy.
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
Risk for developing infection or lymphoma due to allelic variation in genes of immune system that specialize in pathogen recognition compared to absence of allelic variation.
Time frame: 6 years
1 secondary outcome
Risk for developing infectns due to somatic mutatns/polymorphisms in genes involved in signaling pathways downstream of receptors of immune recognitn.Characterize in vitro diff in functional responses to pathogens among genetic variants.
Time frame: 6 years
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 20 Jan 2011.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Genovefa Papanicolaou, MD principal investigator
Memorial Sloan Kettering 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 Infections, run by Memorial Sloan Kettering 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 5 inclusion and 3 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 20 Jan 2011. 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?
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.
What does the primary outcome measure?
Risk for developing infection or lymphoma due to allelic variation in genes of immune system that specialize in pathogen recognition compared to absence of allelic variation. (time frame: 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 20 Jan 2011.