Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT02188758
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2014-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bacterial DNA and RNA will be isolated from sputum samples and stored for future analyses.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Sputum SDI After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for Simpson Diversity Index (SDI) for each subject.'}, {'measure': 'Change in Sputum Pseudomonas aeruginosa Gene Expression After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratios for selected Pseudomonas aeruginosa mRNA transcript levels.'}, {'measure': 'Change in Peripheral Blood Mononuclear Cell (PBMC) Gene Expression After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratios for selected mRNA transcript levels.'}], 'primaryOutcomes': [{'measure': 'Change in Serum Hepcidin-25 Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'The primary endpoint of this study is the characterization of 3 groups (i.e., "low," "intermediate," and "high") of serum hepcidin-25 responders to CFPE treatment. Response will be defined as the ratio of post- to pre-treatment serum hepcidin-25 concentration for each subject.'}], 'secondaryOutcomes': [{'measure': 'Change in Percent-Predicted Forced Expiratory Volume in One Second (FEV1%) After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for FEV1% for each subject.'}, {'measure': 'Change in Body Mass Index (BMI) After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for BMI for each subject.'}, {'measure': 'Change in CFRSD-CRISS Score After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'CFRSD-CRISS is a patient-reported outcome (PRO) instrument developed by the Seattle Quality of Life Group at the University of Washington and used herein under license to evaluate the severity of symptoms of CF in adults and adolescents (≥12 years) with a chronic respiratory infection. Symptoms assessed in the CFRSD-CRISS are: difficulty breathing, cough, cough up mucus, chest tightness, wheeze, feeling feverish, tired, and chills/sweats. The 8 items quantify symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recovery from an exacerbation. We will determine the within-subject differences in CFRSD-CRISS score associated with CFPE treatment.'}, {'measure': 'Change in Serum Iron After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for serum iron concentration for each subject.'}, {'measure': 'Change in Serum Interleukin-6 (IL-6) Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for serum interleukin-6 (IL-6) concentration for each subject.'}, {'measure': 'Change in Sputum Iron Content After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for sputum iron content for each subject.'}, {'measure': 'Change in Serum EPO Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for serum erythropoietin (EPO) for each subject.'}, {'measure': 'Change in Transferrin Saturation After Hospitalization for CF Pulmonary Exacerbation Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for transferrin saturation for each subject.'}, {'measure': 'Change in Serum TREM-1 Concentration After Hospitalization for CF Pulmonary Exacerbation Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for serum triggering receptor expressed on myeloid cells-1 (TREM-1) for each subject.'}, {'measure': 'Change in Serum sIL-6R Concentration After Hospitalization for CF Pulmonary Exacerbation Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for serum soluble IL-6 receptor (sIL-6R) concentration for each subject.'}, {'measure': 'Change in Hemoglobin Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment', 'timeFrame': 'Duration of hospitalization, an expected average of 12 days', 'description': 'Post- to pre-treatment ratio for serum hemoglobin concentration for each subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['iron', 'hepcidin-25', 'pulmonary exacerbation', 'interleukin-6'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '24795218', 'type': 'BACKGROUND', 'citation': 'Gifford AH. What is hepcidin telling us about the natural history of cystic fibrosis? J Cyst Fibros. 2015 Jan;14(1):155-7. doi: 10.1016/j.jcf.2014.03.012. Epub 2014 Apr 30. No abstract available.'}, {'pmid': '24332997', 'type': 'BACKGROUND', 'citation': "Gifford AH, Alexandru DM, Li Z, Dorman DB, Moulton LA, Price KE, Hampton TH, Sogin ML, Zuckerman JB, Parker HW, Stanton BA, O'Toole GA. Iron supplementation does not worsen respiratory health or alter the sputum microbiome in cystic fibrosis. J Cyst Fibros. 2014 May;13(3):311-8. doi: 10.1016/j.jcf.2013.11.004. Epub 2013 Dec 13."}, {'pmid': '23867071', 'type': 'BACKGROUND', 'citation': 'Gifford AH. Hemoglobin </= 12.9 g/dl predicts risk of antibiotic treatment in cystic fibrosis. J Cyst Fibros. 2014 Jan;13(1):114-5. doi: 10.1016/j.jcf.2013.06.007. Epub 2013 Jul 16. No abstract available.'}, {'pmid': '22883617', 'type': 'BACKGROUND', 'citation': "Gifford AH, Moulton LA, Dorman DB, Olbina G, Westerman M, Parker HW, Stanton BA, O'Toole GA. Iron homeostasis during cystic fibrosis pulmonary exacerbation. Clin Transl Sci. 2012 Aug;5(4):368-73. doi: 10.1111/j.1752-8062.2012.00417.x. Epub 2012 Jun 1."}, {'pmid': '20963784', 'type': 'BACKGROUND', 'citation': "Gifford AH, Miller SD, Jackson BP, Hampton TH, O'Toole GA, Stanton BA, Parker HW. Iron and CF-related anemia: expanding clinical and biochemical relationships. Pediatr Pulmonol. 2011 Feb;46(2):160-5. doi: 10.1002/ppul.21335. Epub 2010 Oct 20."}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to identify chemical compounds in the blood and sputum (i.e., biomarkers) that are associated with objective measurements of health status in patients with cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a protein that regulates how the body uses and stores iron, vary during CF pulmonary exacerbation (CFPE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients greater than', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (required at screening visit):\n\n* Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR mutation analysis;\n* History of consistent sputum production on most occasions;\n* FEV1% greater than or equal to 75% of best measurement in previous 6 months;\n* 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the previous year;\n* Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score \\<5);\n* Not admitted to hospital within the previous 3 weeks;\n* Body weight greater than or equal to 75% of best measurement in previous 6 months;\n* Provision of signed informed-consent to study protocol;\n* 18\\<Age\\>65\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating;\n* Subject does not meet Inclusion criteria;\n* Recent and/or persistent visible blood in sputum (hemoptysis);\n* Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression'}, 'identificationModule': {'nctId': 'NCT02188758', 'briefTitle': 'Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Do Changes in Serum Hepcidin-25 Concentration Predict Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment Responses?', 'orgStudyIdInfo': {'id': 'D14136'}, 'secondaryIdInfos': [{'id': 'KL2TR001088', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR001088', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults - CFPE Treatment', 'description': 'Other: CF Pulmonary Exacerbation (CFPE) Treatment', 'interventionNames': ['Other: Adults - CFPE Treatment']}], 'interventions': [{'name': 'Adults - CFPE Treatment', 'type': 'OTHER', 'description': 'Hospitalization for comprehensive treatment of CF pulmonary exacerbation, including intravenous (IV) antibiotics, nutritional assessment and support, airway clearance of mucus, use of inhaled mucolytic agents and bronchodilators, glycemic control with insulin, and psychosocial support.', 'armGroupLabels': ['Adults - CFPE Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04106', 'city': 'South Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.64147, 'lon': -70.24088}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'MaineHealth', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Alex H. Gifford', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}