- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00001257
Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses
Comparison of Inflammatory Responses in Normal Volunteers and Patients With Abnormal Phagocyte Function Using the Suction Blister Technique
This study will investigate the inflammatory response. People with abnormal regulation of inflammation and immune defects often have an exaggerated or depressed inflammatory response that results in poor healing of recurrent infections. This study will measure and compare amounts of inflammatory mediators (chemicals involved in the inflammatory response) in healthy normal volunteers and in patients with abnormal immune responses.
Healthy normal volunteers and patients with host defense defects or excessive inflammation, as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65 years of age.
Participants will have eight small blisters raised on the forearm using a gentle suction device. The top of the blisters will be removed with scissors and a plastic template will be placed over the blisters. The wells of the template will be filled with a salt solution or a mixture of the subject s serum (fluid part of the blood without cells) and a salt solution. Some blisters may be covered with coverslips a small round piece of very thin sterilized glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and 24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the blisters and fall off in about 2 weeks.
Participants will have about 4 tablespoons of blood drawn in order to compare the inflammatory mediators in the blood with those in the blister fluid.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Maryland
-
Bethesda, Maryland, Verenigde Staten, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
- INCLUSION CRITERIA - PATIENTS:
Patients having or thought to have an immune defect between the ages of 6 and 65 years (inclusive) are eligible to participate.
INCLUSION CRITERIA - NORMAL VOLUNTEERS:
Be a healthy adult of either sex and between the ages of 18 and 65 years old.
Weight greater than 110 pounds.
Not have any heart, lung, or kidney disease, or bleeding disorders.
Not have a history of viral hepatitis (B or C) since age 11.
Not have a history of intravenous injection drug use.
Not have a history of engaging in high-risk activities for exposure to the AIDS virus.
Not be pregnant.
EXCLUSION CRITERIA - PATIENTS:
Patients less than 6 or greater than 65 years of age.
EXCLUSION CRITERIA - NORMAL VOLUNTEER:
Less than 18 years old or older than 65 years.
Have viral hepatitis (B or C).
HIV positive.
Receiving chemotherapeutic agent(s), or have underlying malignancy.
Pregnant.
Have history of heart, lung, kidney disease, or bleeding disorders.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects.
Tijdsspanne: Ongoing
|
Ongoing
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Kol A Zarember, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID)
Publicaties en nuttige links
Algemene publicaties
- Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. No abstract available.
- Hellum KB, Solberg CO. Human leucocyte migration: studies with an improved skin chamber technique. Acta Pathol Microbiol Scand C. 1977 Dec;85C(6):413-23. doi: 10.1111/j.1699-0463.1977.tb03663.x.
- Kuhns DB, Long Priel DA, Gallin JI. Loss of L-selectin (CD62L) on human neutrophils following exudation in vivo. Cell Immunol. 1995 Sep;164(2):306-10. doi: 10.1006/cimm.1995.1174.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 900120
- 90-I-0120
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gezonde vrijwilligers
-
University of LeicesterNational Institute for Health Research, United KingdomVoltooidPatiënten met hartfalen en behouden ejectiefractie - HFpEF | Patiënten met hartfalen met verminderde ejectiefractie - HFrEF | Healthy Controls Group - Leeftijd en geslacht afgestemd
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesBeëindigdZiekte van Parkinson | Healthy Controls Group - Leeftijd en geslacht afgestemdFrankrijk