Cystic Fibrosis and Frailtyh What's in Common?
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ClinicalTrials.gov Identifier: NCT06020547 |
Recruitment Status :
Completed
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
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Condition or disease |
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Frailty Syndrome Cystic Fibrosis |
Study Type : | Observational |
Actual Enrollment : | 139 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Cystic Fibrosis in Adults and Frailty |
Actual Study Start Date : | May 1, 2022 |
Actual Primary Completion Date : | June 1, 2023 |
Actual Study Completion Date : | August 1, 2023 |
Group/Cohort |
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Adults with Cystic Fibrosis
All patients who met the diagnostic criteria for CF, over 18 years old, with pathological sweat chloride levels (chloride >60 mEq/L) and two CFTR mutations were recruited. Sweat chloride levels have been tested, and a panel of CFTR mutations screened. The CFTR genotype has been defined through the screening of the most frequent mutations and rearrangements. |
- Pre-Frail/Frail Status [ Time Frame: through study completion, an average of 1 year ]Frailty has been assessed by the SOF Index
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- who met the diagnostic criteria for CF,
- over 18 years old,
- pathological sweat chloride levels (chloride >60 mEq/L) and two CFTR mutations
Exclusion Criteria:
- who did not meet the diagnostic criteria for CF
- under 18 years old
- over 18 years old with normal sweat chloride levels (chloride >60 mEq/L)
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): NCT06020547
Italy | |
Cystic Fibrosis for the Adults Centre | |
Napoli, Italy, 80131 |
Principal Investigator: | Graziamaria Corbi, MD, PhD | Federico II University |
Responsible Party: | Graziamaria Corbi, Associate Professor, Federico II University |
ClinicalTrials.gov Identifier: | NCT06020547 |
Other Study ID Numbers: |
CysFiFRa |
First Posted: | August 31, 2023 Key Record Dates |
Last Update Posted: | August 31, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | the data will be treated as pooled |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
functional status frailty Cystic Fibrosis geriatric syndrome |
Cystic Fibrosis Fibrosis Frailty Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |