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Malaria Clinical Trials Center General Screening (GS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02119312
Recruitment Status : Suspended (COVID19 safety measures-institutional policy to suspend non-covid related studies)
First Posted : April 21, 2014
Last Update Posted : June 16, 2020
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief 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.

Condition or disease

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: General Screening for Eligibility to Participate in Treatment, Prevention and Vaccine Trials at the Seattle Malaria Clinical Trials Center
Study Start Date : June 2010
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Participant Enrollment [ Time Frame: Once upon enrollment ]
    See inclusion/exclusion criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men and non-pregnant women who are in general good health.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02119312

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
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Principal Investigator: James G Kublin, MD Fred Hutchinson Cancer Research Center
Additional Information:
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Responsible Party: Fred Hutchinson Cancer Research Center Identifier: NCT02119312    
Other Study ID Numbers: MC-002
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Keywords provided by Fred Hutchinson Cancer Research Center:
Plasmodium falciparum
Clinical Trials
Vaccine Study
Drug Study
Malaria Clinical Trials Center
Seattle BioMed
Center for Infectious Disease Research
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases