Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-13 @ 8:28 AM
Study NCT ID:
NCT02399150
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2015-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Acute Abdomen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000006', 'term': 'Abdomen, Acute'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'EDTA and serum blood, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic value of biomarkers for discriminating between self-limiting abdominal pain and acute surgical emergency', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute abdomen', 'Pain', 'stress biomarker'], 'conditions': ['Acute Abdominal Pain']}, 'referencesModule': {'references': [{'pmid': '41189107', 'type': 'DERIVED', 'citation': 'Blum CA, Faron M, Paquet AL, Velly L, Brochet C, Tresallet C, Hausfater P. Biomarkers for Detecting Surgical Emergency in Acute Abdomen-A Prospective Observational Study. J Appl Lab Med. 2025 Nov 4;10(6):1537-1551. doi: 10.1093/jalm/jfaf137.'}]}, 'descriptionModule': {'briefSummary': 'Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.\n\nObjective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.\n\nDesign: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.\n\nEstimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.\n\nStudy population: 200 patients presenting to the ED with acute abdomen\n\nEligibility criteria:\n\n* Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years\n* Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance\n\nProcedure:\n\nPatients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.\n\nMeasurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.\n\nSafety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.\n\nSample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.\n\nSignificance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients presenting to the ED with acute abdomen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presentation at ED with acute abdominal pain, aged at least 18 years\n\nExclusion Criteria:\n\n* No informed consent, pregnancy, homeless, no social assurance'}, 'identificationModule': {'nctId': 'NCT02399150', 'acronym': 'BIOMAB', 'briefTitle': 'Biomarkers in Acute Abdomen', 'organization': {'class': 'OTHER', 'fullName': 'Pitié-Salpêtrière Hospital'}, 'officialTitle': 'Biomarkers in Acute Abdomen (BIOMAB)', 'orgStudyIdInfo': {'id': 'BIOMAB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Abdominal Pain', 'description': 'patients presenting to the ED with acute abdomen', 'interventionNames': ['Other: No intervention as observational study']}], 'interventions': [{'name': 'No intervention as observational study', 'type': 'OTHER', 'armGroupLabels': ['Acute Abdominal Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': "Service d'Accueil des Urgences, CHU Pitié-Salpêtrière", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre Hausfater, MD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Accueil des Urgences, CHU Pitié-Salpêtrière, AP-HP et Université Pierre et Marie Curie Paris 06, Paris"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pitié-Salpêtrière Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency Department', 'investigatorFullName': 'Hausfater Pierre', 'investigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'}}}}