Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-05 @ 9:28 PM
Study NCT ID:
NCT02189434
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collection of serum blood specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC.', 'timeFrame': 'end of study'}], 'secondaryOutcomes': [{'measure': "Observe the patient's post-operative course with regards to serum procalcitonin levels and development of sepsis in patients previously treated with cytoreductive surgery with or without HIPEC.", 'timeFrame': 'end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cytoreductive Surgery']}, 'descriptionModule': {'briefSummary': 'Serum procalcitonin levels will be considerably higher, for a longer period of time, in patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients having undergone cytoreductive surgery with or without HIPEC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male person ≥ 18 years of age\n* Biopsy proven carcinoma\n* Scheduled for cytoreductive surgery, with or without HIPEC\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2\n* Able to give informed consent for protocol participation\n\nExclusion Criteria:\n\n* Participants are not able to understand or provide written informed consent\n* Pre-operative anti-inflammatory medication use within 72 hours of their baseline blood draw\n* Pre-operative infection treatment with corticosteroids within 72 hours of their baseline blood draw\n* Immunosuppressive illness other than neoplasm\n* Pregnant or lactating female'}, 'identificationModule': {'nctId': 'NCT02189434', 'briefTitle': 'Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Regional Medical Center'}, 'officialTitle': 'A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery', 'orgStudyIdInfo': {'id': 'ERMC 14-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cytoreductive surgery', 'description': 'Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws', 'interventionNames': ['Other: Serum procalcitonin lab draws']}], 'interventions': [{'name': 'Serum procalcitonin lab draws', 'type': 'OTHER', 'description': 'Blood will be collected in a 4mL capacity, green top lithium heparin tube. Samples can be drawn from a port with other labs. The samples will be centrifuged and then the plasma/serum will be removed and placed into a screw-capped round bottom plastic vial. Samples will be stored at -20○C until processing. Serum samples will be batch processed for each participant at the conclusion of their study period.\n\nThese draws will be conducted for the sole purpose of this study, and whenever possible, they will be performed at the same time as routine blood draws conducted for medical monitoring to reduce the burden to the patients.', 'armGroupLabels': ['Cytoreductive surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19124', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Eastern Regional Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rod Flynn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Regional Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Regional Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}