Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:00 AM
Study NCT ID:
NCT07312734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Enable New Diagnostics for Pulmonary Microbes in People With CF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'Serum, plasma, buffy coat, urine, saliva, sputum, whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-10-23', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate alternative methods for the detection of microbial pathogens from the lungs of people with CF by comparing against the gold standard of sputum cultures.', 'timeFrame': 'Baseline Visit', 'description': 'Specimens (including sputum, saliva, blood, urine, and breath (for the Owlstone Device Sub-Study)) will be collected at the Study Visit. These specimens will be stored at a biorepository and be made available to the research community to test and validate diagnostic assays for the detection of CF pathogens.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'CF', 'Breath collection', 'Specimen collection', 'Detection of pathogens', 'New diagnostics'], 'conditions': ['Cystic Fibrosis (CF)', 'New Diagnostics']}, 'descriptionModule': {'briefSummary': 'Sputum culture has been the best approach to detect harmful bacteria in the lungs of people with cystic fibrosis (CF). With the widespread use of new CF therapies (like Trikafta and Alyftrak), it is more difficult for people with CF to produce sputum even though they still have harmful bacteria in their lungs. The SEND-CF study is being done to see if there are other ways to detect harmful bacteria in the lungs.', 'detailedDescription': 'People with cystic fibrosis (CF) often get lung infections that can make their breathing worse and make their lungs weaker over time. Sputum culture is usually analyzed to find these infections. Currently, many people with CF are using CFTR modulators. These medicines help, but they also make it harder for people to cough up sputum. Even though people with CF are making less sputum, lung infections are still a problem. New ways are needed to check for infections without using sputum.\n\nThe SEND-CF study wants to gather health information and samples from people with CF in order to find new and better ways to spot harmful bacteria in the lungs. Participants, who typically are able to produce sputum who consent to participate will be asked to provide samples including sputum, saliva, serum, plasma, buffy coat, urine, and whole blood. Some participants will also provide breath samples for a sub-study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 16 years of age on day of study visit\n* Documentation of CF Diagnosis\n* Able to expectorate sputum\n* Percent predicted FEV1 ≥ 30%\n\nExclusion Criteria:\n\n* History of solid organ transplantation\n* History of active malignancy (or treatment for malignancy) in 12 months prior to the study visit\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT07312734', 'acronym': 'SEND-CF', 'briefTitle': 'Study to Enable New Diagnostics for Pulmonary Microbes in People With CF', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Study to Enable New Diagnostics for Pulmonary Microbes in People With CF (SEND-CF)', 'orgStudyIdInfo': {'id': 'SENDCF-OB-25'}}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jenna Mielke', 'role': 'CONTACT', 'email': 'jmielke@health.ucsd.edu', 'phone': '619-471-0822'}], 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'CF Trials Contact University of Minnesota, Participant Contact', 'role': 'CONTACT', 'email': 'cftrials@umn.edu'}], 'facility': 'The Minnesota Cystic Fibrosis Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'contacts': [{'name': 'Irma Bauer', 'role': 'CONTACT', 'email': 'irmabauer@wustl.edu'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '69198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'contacts': [{'name': 'Michel Veit', 'role': 'CONTACT', 'email': 'michel.veit@unmc.edu'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Diana Gilmore', 'role': 'CONTACT', 'email': 'Diana.Gilmore@nationwidechildrens.org'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Melissa Molter', 'role': 'CONTACT', 'email': 'melissa.molter@pennmedicine.upenn.edu'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Adrienne DeRicco', 'role': 'CONTACT', 'email': 'adrienne.dericco2@upmc.edu'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Ashley Keller', 'role': 'CONTACT', 'email': 'Ashley.Keller@UTSouthwestern.edu'}], 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Erin Hubertz', 'role': 'CONTACT', 'email': 'ehubertz@mcw.edu'}], 'facility': 'Froedtert & Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Nikita Midamba', 'role': 'CONTACT', 'email': 'Nikita.midamba@seattlechildrens.org', 'phone': '206-884-0599'}, {'name': 'Anna Mead', 'role': 'CONTACT', 'email': 'Anna.mead@seattlechildrens.org', 'phone': '206-884-7531'}], 'overallOfficials': [{'name': 'Gina Hong, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chris Goss', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Pediatrics, University of Washington', 'investigatorFullName': 'Chris Goss', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}