Tissue Collection From People With Cystic Fibrosis
Tissue Collection Protocol for Individuals With Cystic Fibrosis
This study will examine the relationship between bacterial products in lung infections in cystic fibrosis and disease severity. It will examine plasma and lung tissue from cystic fibrosis patients.
Patients with cystic fibrosis and having certain genetic characteristics, who are between 9 and 65 years of age and any cystic fibrosis patient undergoing lung transplantation at INOVA Fairfax Hospital in Fairfax, Virginia, may be eligible for this study.
Patients who cannot undergo apheresis may be asked to provide up to an additional 100 cc (7 tablespoons) of blood for research to look at bacterial products.
Lung specimens of participating transplant patients will be collected at INOVA Fairfax Hospital. Patients who participate in the apheresis portion of the study will be admitted to the NIH Clinical Center for 2 to 3 days. Apheresis is a procedure for collecting large quantities of specific blood components. For this study, plasma-the liquid part of the blood-will be collected. For the procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated into its components by centrifugation (spinning), the plasma and white cells are extracted and collected in a bag, and the red cells are returned to the body, either through the same needle or through another needle in the other arm.
During the hospital stay, patients may also be asked to participate in other cystic fibrosis studies involving blood tests, an echocardiogram (ultrasound test of the heart), urine pregnancy test, and pulmonary function (breathing) tests.
調査の概要
状態
条件
詳細な説明
研究の種類
入学
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
- INCLUSION CRITERIA:
Individuals with CF with an identified mutation in the cystic fibrosis transmembrance regulator (CFTR) (i.e., any of the known variants of the CFTR gene, such as the change in F508 allele) who are between the ages of 18 years to 65 years will be included in the apheresis portion of the study. Patients will have been or will be genotyped under another protocol. Patients must be colonized or have a history of colonization with P. aeruginosa. Patients may have cultured other organisms (e.g., Burkholderia cepacia).
All patients undergoing lung transplantation will be included in the study. Based on data from various CF registries, the mean age for patients receiving transplant is 26 years with a range from 5 to 59 years. Any patient age 9 and over with CF undergoing transplantation will be eligible for the explantation portion of the study.
EXCLUSION CRITERIA:
There are no exclusion criteria for subjects in the transplant portion of the study.
Patients with CF will be excluded from the apheresis portion of the study if they are less than 18 years, weigh less than 40kg, or demonstrate:
- Cardiovascular instability;
- Severe anemia (hematocrit less than 28 percent, hemoglobin less than10gm/ml);
- Thrombocytopenia (Platelets less than 50,000);
- Inadequate venous access in the upper extremities (No central venous catheters will be used);
- Severe coagulation disorder;
- Positive serology for hepatitis B, C, or HIV;
- Pregnancy;
- Pulmonary hypertension;
- Respiratory exacerbation requiring intravenous antibiotics;
- Any other condition which the physician or Apheresis Unit staff considers a contraindication to the procedure.
Individuals who are unable to provide adequate consent/assent will be excluded from the study.
研究計画
研究はどのように設計されていますか?
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。