Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 9:05 AM
Study NCT ID:
NCT02799251
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D008231', 'term': 'Lymphopenia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of post operative infection', 'timeFrame': '1 month', 'description': 'Patients undergoing general anesthesia for thoracic or digestive surgery could present lymphopenia. In this situation, the presence of post operative infection is notified. The correlation between lymphopenia and post operative infections is studied.'}], 'secondaryOutcomes': [{'measure': 'Anesthetic and surgical parameters', 'timeFrame': '1 month', 'description': 'To identify anesthetic and surgical parameters influencing postoperative lymphocytes cells count.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lymphopenia', 'postoperative infection', 'thoracic cancer surgery', 'digestive cancer surgery'], 'conditions': ['Cancer of the Digestive System', 'Thoracic Diseases']}, 'referencesModule': {'references': [{'pmid': '39474711', 'type': 'DERIVED', 'citation': 'Petit L, Pastene B, Dupont G, Baffeleuf B, Goulevant PA, Fellahi JL, Gricourt Y, Lebuffe G, Ouattara A, Fischer MO, Mertes PM, Eyraud D, Bouhemad B, Gomola A, Montravers P, Alingrin J, Flory L, Incagnoli P, Boisson M, Leone M, Monneret G, Lukaszewicz AC, Pereira B, Molliex S; for the EVALYMPH study group. Postoperative lymphopaenia as a risk factor for postoperative infections in cancer surgery: A prospective multicentre cohort study (the EVALYMPH study). Eur J Anaesthesiol. 2025 Mar 1;42(3):244-254. doi: 10.1097/EJA.0000000000002089. Epub 2024 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.', 'detailedDescription': 'Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis.\n\nThe aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery. It is a multicenter French cohort study. Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery before surgery (day-0) as well 1, 3, 5 and 8 days after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient undergoing digestive or thoracic cancer surgery under general anesthesia.\n\nExclusion Criteria:\n\n* pregnant women,\n* malignant blood disease,\n* allograft patient,\n* preoperative sepsis or preoperative systemic inflammatory response syndrome.'}, 'identificationModule': {'nctId': 'NCT02799251', 'acronym': 'EVALYMPH', 'briefTitle': 'Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study', 'orgStudyIdInfo': {'id': '1600010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Collection of plasma cell rate', 'description': 'Post operative infections and their association with lymphopenia are assessed in this study for patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.', 'interventionNames': ['Other: Collection of plasma cell rate']}], 'interventions': [{'name': 'Collection of plasma cell rate', 'type': 'OTHER', 'description': 'Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery. The rates are assessed before surgery (day 0) and at days 1, 3, 5 and 8 after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.', 'armGroupLabels': ['Collection of plasma cell rate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Chu Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '14003', 'city': 'Caen', 'country': 'France', 'facility': 'Hôpital Côtes de Nacre CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63100', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hôpital Estaing CHU CLERMONT-FERRAND', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon CHU PARIS 1', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'Hôpital Michallon CHU GRENOBLE', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Huriez CHRU LILLE', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot CHU LYON', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital La croix Rousse CHU LYON', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Lyon Sud CHU LYON', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Nord CHU MARSEILLE', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital La Timone CHU MARSEILLE', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Hôpital Hôtel-Dieu CHU NANTES', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Hôpital Carémeau CHU NIMES', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis-Lariboisière CHU PARIS 5', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Antoine CHU PARIS 4', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital La pitié-Salpetrière CHU PARIS 3', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Bichat CHU PARIS 2', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Hôpital Pontchaillou CHU RENNES', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital Central CHRU STRASBOURG', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre de Lutte contre le Cancer, TOULOUSE', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Serge Molliex, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}