MalariaGSNCT02119312
Malaria Clinical Trials Center General Screening
An observational study of Malaria, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to identify and screen potential subjects for preliminary eligibility to participate in a malaria related clinical trial conducted at the Seattle Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 2,101 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 1 Sep 2020
- How long will I take part?
- 1 Year
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Men and non-pregnant women who are in general good health.
Who may be able to join
- Good general health status as demonstrated by medical history, physical exam, and screening laboratory tests;
- No history of certain chronic medical illnesses (e.g. diabetes, epilepsy, autoimmune disease, hepatitis, heart disease);
- HIV, Hepatitis B and C negative;
- Low risk for coronary heart disease;
- Ability and willingness to provide informed consent;
- Reliable access to the MCTC and associated sites; and
- If participant is biologically female she must not be pregnant and must agree to consistently use an effective form of birth control 21 days prior to enrollment in an active clinical study and for the duration of that study.
Who cannot join
- Prior receipt of an investigational malaria vaccine;
- Chronic use of systemic antibiotics or immunosuppressive medications with anti-malarial effects;
- Chronic medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status;
- History of systemic anaphylaxis;
- History of, or known active cardiac disease;
- Elevated (moderate of high) risk of coronary heart disease;
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- Clinically significant ECG findings;
- Chronic or active neurological disease;
- History of splenectomy or functional asplenia;
- History of psoriasis or porphyria;
- History of diagnosed ocular disease;
- Positive history of HIV, Hepatitis B and/or C;
- Pregnant or lactating females or females who intend to become pregnant during study period;
- Certain psychiatric conditions that could affect study compliance; and
- Suspected or known current alcohol and/or drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: General Screening for Eligibility to Participate in Treatment, Prevention and Vaccine Trials at the Seattle Malaria Clinical Trials Center
The purpose of this study is to identify and screen potential subjects for preliminary eligibility to participate in a malaria related clinical trial conducted at the Seattle Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.
Read the detailed description
This is a continuous study enrolling approximately 350 participants per year to establish preliminary eligibility for participation in ongoing or future Seattle Malaria Clinical Trials Center (Seattle MCTC) clinical research studies. Data collected may be used to support preliminary eligibility for a current or future Seattle MCTC clinical research study.
In order to maximize efficiency of the screening process potential participants who contact the site will be pre-screened using an IRB-approved screening form.
Potential participants who contact the site may be asked to come in for an in-person screening visit. They will be given a consent form to read and sign if they should choose to participate in the screening process. If they have any questions during this process research staff will be available. This visit includes an in-depth medical history review, travel history, physical exam, blood draw, electrocardiogram test (ECG), and a urine test.
The Seattle Malaria Clinical Trials Center (Seattle MCTC) is conducting research to combat malaria. Malaria is a disease that is transmitted to humans by the bite of an infected mosquito and affects millions of people worldwide. Malaria can cause a wide range of medical problems, and may even result in death if the infection is not treated. Currently there are many medications, preventative measures and malaria vaccines being developed to fight malaria that will need to be tested before they can be made available to the general public. The Seattle MCTC is conducting clinical research studies for this purpose and is in need of healthy adult volunteers to take part in upcoming studies.
- Conditions
- Malaria
- Keywords
- Malaria, Plasmodium, Plasmodium falciparum, Clinical Trials, Vaccine Study, Drug Study, Malaria Clinical Trials Center, Seattle BioMed, Center for Infectious Disease Research
- Medical subject headings
- Malaria, Malaria, Falciparum
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Enrollment
See inclusion/exclusion criteria.
Measured: Once upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2010
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- 2,101 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James G Kublin, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119312
- Sponsor's protocol ID
- MC-002
- Acronym
- GS
- Status last verified
- Sep 2020
- First submitted
- 16 Apr 2014
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Screening for Eligibility to Participate in Treatment, Prevention and Vaccine Trials at the Seattle Malaria Clinical Trials Center
- ClinicalTrials.gov ID
- NCT02119312
- Acronym / sponsor ID
- GS / MC-002
- Conditions
- Malaria
- Keywords
- Malaria, Plasmodium, Plasmodium falciparum, Clinical Trials, Vaccine Study, Drug Study, Malaria Clinical Trials Center, Seattle BioMed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,101 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 21 Apr 2014 (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 identify and screen potential subjects for preliminary eligibility to participate in a malaria related clinical trial conducted at the Seattle Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.
Detailed description
This is a continuous study enrolling approximately 350 participants per year to establish preliminary eligibility for participation in ongoing or future Seattle Malaria Clinical Trials Center (Seattle MCTC) clinical research studies. Data collected may be used to support preliminary eligibility for a current or future Seattle MCTC clinical research study.
In order to maximize efficiency of the screening process potential participants who contact the site will be pre-screened using an IRB-approved screening form.
Potential participants who contact the site may be asked to come in for an in-person screening visit. They will be given a consent form to read and sign if they should choose to participate in the screening process. If they have any questions during this process research staff will be available. This visit includes an in-depth medical history review, travel history, physical exam, blood draw, electrocardiogram test (ECG), and a urine test.
The Seattle Malaria Clinical Trials Center (Seattle MCTC) is conducting research to combat malaria. Malaria is a disease that is transmitted to humans by the bite of an infected mosquito and affects millions of people worldwide. Malaria can cause a wide range of medical problems, and may even result in death if the infection is not treated. Currently there are many medications, preventative measures and malaria vaccines being developed to fight malaria that will need to be tested before they can be made available to the general public. The Seattle MCTC is conducting clinical research studies for this purpose and is in need of healthy adult volunteers to take part in upcoming studies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men and non-pregnant women who are in general good health.
Key inclusion criteria (7 listed)
- Good general health status as demonstrated by medical history, physical exam, and screening laboratory tests;
- No history of certain chronic medical illnesses (e.g. diabetes, epilepsy, autoimmune disease, hepatitis, heart disease);
- HIV, Hepatitis B and C negative;
- Low risk for coronary heart disease;
- Ability and willingness to provide informed consent;
Key exclusion criteria (15 listed)
- Prior receipt of an investigational malaria vaccine;
- Chronic use of systemic antibiotics or immunosuppressive medications with anti-malarial effects;
- Chronic medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status;
- History of systemic anaphylaxis;
- History of, or known active cardiac disease;
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
Participant Enrollment
Time frame: Once upon enrollment
See inclusion/exclusion criteria.
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 14 Sep 2020.
- Seattle Malaria Clinical Trials 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.
James G Kublin, MD principal investigator
Fred Hutchinson 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 Malaria, run by Fred Hutchinson 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 7 inclusion and 15 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 14 Sep 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?
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?
Participant Enrollment (time frame: Once upon enrollment). 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 Sep 2020.