Studying Patients With Cystic Fibrosis and Other Pulmonary and Pancreatic Disorders
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001223|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : August 7, 2020
Cystic fibrosis is a disease that affects many parts of the body, particularly the lungs and pancreas. The main purpose of this study is to further understand the natural history, clinical presentation, and genetics of cystic fibrosis.
Patients with cystic fibrosis will be asked to participate in this study by undergoing standard medical tests and procedures. Patients will have a history taken and have a physical examination as well as blood tests, and a sweat test (a test for cystic fibrosis of the pancreas in which electrolytes are measured in collected sweat). Patients may also be asked to provide samples of urine, stool, and sputum for additional tests. More complicated procedures such as bronchoscopy or bronchoalveolar lavage may be required for diagnosis, treatment, or research purposes.
Patients will receive appropriate treatment with antibiotics, pancreatic enzymes, vitamins, physiotherapy, and other agents. Medications may be given by mouth or injected into a vein.
This study will provide patients with information on the prognosis of the disease as well as recommendations for management of cystic fibrosis. In addition this study will provide information to researchers which may be useful in other studies of cystic fibrosis.
|Condition or disease|
This is an omnibus protocol for studying patients with cystic fibrosis and other familial
pulmonary and pancreatic disorders. The main purpose of the study is to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis. A well-characterized population of patients with cystic fibrosis will be invited to provide appropriate specimens for laboratory research and to participate in clinical trials of therapeutic agents for cystic fibrosis.
|Study Type :||Observational|
|Estimated Enrollment :||9999 participants|
|Official Title:||Diagnosis and Treatment of Patients With Cystic Fibrosis and Other Disorders of the Respiratory System and Pancreas|
|Actual Study Start Date :||January 1, 1988|
cystic fibrosis patients
relatives of cystic fibrosis patients
- Preservation of pulmonary function [ Time Frame: annually ]pulmonary function tests, laboratory data, follow-up of height and weight, vital signs. Changes in physical examination, changes in routine laboratory data including urine, blood, chemistry, microbiology of sputum and bronchovial lavage if done, cytology, radiology studies, supplemental feeding and oxygen, supplemental pancreatic enzymes and vitamins, antibiotics (oral, inhaled, and/or IV), collected demographic data, complications, transplants and post-transplant care
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 ClinicalTrials.gov identifier (NCT number): NCT00001223
|Contact: Milica S Chernick, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Milica S Chernick, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|