Detection of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Activity in Rectal Tissues From Human Subjects
Completed
Conditions studied: Cystic Fibrosis
In brief
This is a pilot study. The purpose of the study is to facilitate the development of a new biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) function using rectal tissue.
Key facts
- Study ID
- NCT01078740
- Run by
- CF Therapeutics Development Network Coordinating Center
- People needed
- 57
- Starts
- 2009-10-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2013-03-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female 18-75 years of age at enrollment
- Undergoing colonoscopy for clinical care
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
You may not qualify if…
- Any medical condition or laboratory values that in the opinion of the onsite principal investigator and/or collaborating gastroenterologist may place the subject at significant risk by undergoing the additional research related biopsies
- Subjects with a history of radiation therapy to the rectum, prostate and/or pelvic area
- CF subjects undergoing a surgical procedure for clinical care
- Inclusion Criteria:
- Confirmed diagnosis of CF based on the following criteria: ∆F508 homozygous
- Male or female 18 years of age or greater at enrollment
- Patient undergoing planned colonoscopy or other surgical procedure and agrees to undergo sigmoidoscopy and biopsy
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
- Exclusion Criteria:
- Any medical condition or laboratory values that in the opinion of the onsite principal investigator and/or collaborating gastroenterologist may place the subject at significant risk by undergoing the additional research related biopsies, including:
- Significantly diseased distal rectal/gastrointestinal (GI) tissue (as judged by the collaborating gastroenterologist including radiation injury or history of radiation therapy to the rectum, prostate and/or pelvic area
- Significant hemorrhoids or vascular abnormalities (as judged by the collaborating gastroenterologist)
- Significant colonic infection (as judged by the collaborating gastroenterologist)
- CF subjects undergoing sigmoidoscopy biopsy procedure for study purposes only
- Inclusion Criteria:
- Confirmed diagnosis of CF based on the following criteria: ∆F508 homozygous
- Male or female 18 years of age or greater at enrollment
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
- CBC, PT/PTT within acceptable range (see exclusion criteria for values) within 14 days of the procedure
- Negative pregnancy test (if applicable) completed within two (2) days of the procedure
- Exclusion Criteria:
- Any medical condition or laboratory values that in the opinion of the onsite principal investigator and/or collaborating gastroenterologist may place the subject at significant risk by undergoing the additional research related biopsies, including:
- Bleeding diathesis (platelets <50,000, INR >1.5)
- Anemia (hemoglobin <10 gm/dL, or hematocrit <30%
- White blood count >20,000
Where it is running
- University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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