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Studying Patients With Cystic Fibrosis and Other Pulmonary and Pancreatic Disorders

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ClinicalTrials.gov Identifier: NCT00001223
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:

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
Cystic Fibrosis

Detailed Description:

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 : 99999999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Treatment of Patients With Cystic Fibrosis and Other Disorders of the Respiratory System and Pancreas
Study Start Date : February 18, 1987

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA

Patients and family members with known or suspected CF and related disorders of the respiratory tract or pancreas as defined by clinical presentation, sweat testing and/or genotyping.

Willingness of patients, or guardian to give informed consent.

EXCLUSION CRITERIA

Age less than 4 years.

Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.


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 ClinicalTrials.gov identifier (NCT number): NCT00001223


Contacts
Contact: Milica S Chernick, M.D. (301) 496-3434 milicac@bdg10.niddk.nih.gov

Locations
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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Milica S Chernick, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00001223     History of Changes
Other Study ID Numbers: 870029
87-DK-0029
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 29, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Cystic Fibrosis
Pancreatic Insufficiency
Bronchiectasis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases