A MULTI-CENTER STUDY OF NON-INVASIVE COLORECTAL CANCER EVALUATION IN CYSTIC FIBROSIS (NICE-CF)

Date Added
December 1st, 2022
PRO Number
Pro00124304
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis
Summary

This is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA-based test and quantitative FIT test) to standard of care colonoscopy for CRC screening in PwCF. The study includes an enrollment visit, two stool samples completed at home, a clinical screening colonoscopy, and three participant surveys which will be completed at enrollment and remotely.
The total duration of participant participation will be 3-12 months, depending on the timing of the completion of the stool sample and the participant's colonoscopy. The targeted participant timeline is 3 months from enrollment to the completion of a clinical screening colonoscopy. To allow for varying site-specific clinical colonoscopy scheduling delays and COVID delays in scheduling, the duration of time between stool sampling and screening colonoscopy may extend up to 12 months for inclusion of data in the study. However, greater than 3 months duration between stool-based testing and colonoscopy will be considered a protocol deviation.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection

Date Added
October 11th, 2022
PRO Number
Pro00123010
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This study is a randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and tolerability of twice daily inhaled bacteriophages (BX004-A) for up to 10 days in 32 outpatient adult Cystic Fibrosis subjects with chronic PsA pulmonary infections who are currently receiving inhaled antibiotics. This study consists of a screening period and a treatment period, divided into 2 parts. In Part 1, subjects will receive the study drug over 7 days, in part 2 over 10 days. Subjects in both parts will be included in a 6-month safety follow-up. Final safety assessments will include phone calls 28 days and 6 months after the last dose of study medication. Questionnaires will be administered through 28 days after the last dose of study medication. A Data Monitoring Committee (DMC) will monitor safety during both parts of the study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are colonized with Nontuberculous Mycobacteria (the ABATE study)

Date Added
September 1st, 2022
PRO Number
Pro00123092
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Lung, Nontuberculous mycobacteria (NTM), Pulmonary
Summary

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu