Characterization of the Pathogenesis of Primary and Secondary Lymphatic Disorders (NCT02156115) | Clinical Trial Compass
TerminatedNot Applicable
Characterization of the Pathogenesis of Primary and Secondary Lymphatic Disorders
Stopped: Study closed before total enrollment met.
United States14 participantsStarted 2015-03-23
Plain-language summary
Background:
\- Lymphatics are a type of vessel, similar to arteries and veins. Lymphatic disorders happen when these vessels don t work properly. Researchers want to look for a relationship between lymphatic disorders and variations of certain genes found in the lung, blood, and other places in the body.
Objective:
\- To learn more about lymphatic disorders and evaluate how genetic factors affect lymphatic disorders.
Eligibility:
* People ages 2 90 who have a lymphatic disorder or relatives of people with lymphatic disorders.
* Healthy volunteers 18 and older.
Design:
* Participants may have 1 2 visits a year, or more as needed. The study is expected to last 5 years. Visits may last 1 5 days. Participants may have lab tests, medical history, and physical exam at each visit.
* Participants may have blood testing that includes genetics tests, and urine tests. They may have nose and throat cultures, saliva collection, and cheek swabs to collect samples.
* Participants may have a skin biopsy and have blood taken from an artery.
* Participants may have breathing tests and be studied while exercising.
* Participants may have an electrocardiogram. Electrodes will be placed on their chest, tracing heart rhythms. They may also have chest X-rays.
* Participants may have a bronchoscopy. A thin, flexible instrument will be passed through the nose or mouth, into the lung. A tissue sample will be taken.
* Participants who have lymphatic disease or have a relative with it may also have:
* CT scans. They will lie on a table and hold their breath while their chest is scanned.
* MRI. They will lie flat on a table that slides in and out of a scanner.
* ultrasound. A probe is rolled around outside the abdomen.
* removal of fluid around the lungs, chest, and abdomen.
Who can participate
Age range2 Years – 90 Years
SexALL
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Inclusion criteria
✓. Patients 2 years of age or older with clinical or histological evidence for a lymphatic abnormality; patients will in the vast majority of cases be referred with the diagnosis of a lymphatic disorder.
✓. Patients 2 years of age or older with findings on physical examination consistent with the diagnosis of a lymphatic abnormality.
✓. Relatives of patients with lymphatic disorders, 2 years of age or older.
✓. Healthy research volunteers 18 years of age or older as control subjects.
Exclusion criteria
✕. Patients who are less than 2 years of age. Research volunteers less than 18 years of age. Age greater than 90 years old.
✕. Advanced stage of any systemic illness.
✕. An exclusion criterion for participating in the x-ray portion of the study is pregnancy.
✕. Exclusion criteria for participating in the bronchoscopy portion of the study are: (1) presence of any contraindication for fiberoptic bronchoscopy, with lavage and/or bronchial brushing; (2) advanced stage of a pulmonary or a systemic illness such that the risk is judged to be significant even in the absence of a specific contraindication to the procedure; (3) allergy to topical anesthetic (e. g., lidocaine); (4) current or recent respiratory infection (within the last 4 weeks); (5) pregnancy or lactation; (6) age less than 18 or greater than 65.
What they're measuring
1
(a) define the natural history of lymphatic diseases, (b) characterize the clinical phenotypes, and (c) elucidate their pathogenesis at the physiological, cellular and molecular levels.
Timeframe: ongoing
Trial details
NCT IDNCT02156115
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
✕. Exclusion criteria for participating in the endoscopy portion of the study are: (1) Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient; (2) have a history of surgical removal of a portion or all of the colon if it is believed to increase risk; (3) are pregnant; (4) have had radiation to the abdomen or pelvis; (5) have poor heart or lung function that would make sedation too risky; (6) have allergy or other contraindications to midazolam or fentanyl; (7) are unable to tolerate preparation for the procedure; (8) are unable to give consent; (9) have had abdominal surgery within eight weeks; (10) are taking anticoagulant therapy that cannot be interrupted; (11) have had diverticulitis or an abdominal abscess within eight weeks.