Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-28 @ 9:24 PM
Study NCT ID:
NCT07200466
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-26', 'size': 1028075, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-09T05:27', 'hasProtocol': True}, {'date': '2025-08-26', 'size': 487658, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-09T05:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will receive a personalized treatment plan based on the risk of lymph node metastases as predicted by the ENDORISK model. Patients with low grade endometrial cancer (EC) (grade I-II) at high risk of lymph node metastases might therefore undergo additional surgical staging, through either sentinel lymph node procedure or lymphadenectomy. Patients with low grade EC (grade I-II) at low-risk of lymph node metastases are counselled to undergo standard treatment, which involves hysterectomy with bilateral salpingo-oophorectomy. Patients with high grade EC (grade III), receive their personalized risk but will undergo standard care to further validate the ENDORISK model in this group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 735}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2032-10-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-09-28', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Charlson-index', 'timeFrame': '12 weeks after primary surgery', 'description': 'Charlson-index as reported by participants and as reported by clinician/researcher from patient records'}, {'measure': 'Health literacy', 'timeFrame': '12 weeks after primary surgery', 'description': 'Health Literacy as reported by participants through a questionnaire'}], 'primaryOutcomes': [{'measure': 'Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care.', 'timeFrame': 'from enrolment to surgery'}, {'measure': 'Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care', 'timeFrame': 'From enrolment to time of surgery', 'description': 'The lymph node metastases in patients undergoing lymph node staging will be determined by pathology report on the surgical specimen. The positive predicting value will be compared to the positive predictive value of standard care.'}, {'measure': 'Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care, measured by questionnaires.', 'timeFrame': 'From enrolment to 12 weeks post-operatively', 'description': 'Information provision score: Questionnaire EORTC Quality of Life Questionnaire (QLQ)-INFO25 with additional questions specific to ENDORISK use.\n\nShared-decision making score: Shared Decision Making Questionnaire SDM-Q-9 with additional questions specific to ENDORISK use'}], 'secondaryOutcomes': [{'measure': "Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care;", 'timeFrame': 'from enrolment to 5-year post surgery'}, {'measure': 'Health related quality of life (HRQoL) compared to standard care', 'timeFrame': '12 weeks after primary surgery', 'description': 'as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30'}, {'measure': 'Health-related quality of life (HRQoL) compared to standard care', 'timeFrame': '12 months after primary surgery', 'description': 'as measured by questionnaire: EORTC QLQ-C30'}, {'measure': 'Treatment-related morbidity compared to standard care', 'timeFrame': '12 weeks after primary surgery', 'description': 'As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24'}, {'measure': 'Treatment related morbidity compared to standard care', 'timeFrame': '12 months after primary surgery', 'description': 'As measured by questionnaire: EORTC QLQ-EN24 and questionnaires about lymphoedema: EORTC IL76 \\& Lymphoedema quality of Life (LYMQOL)'}, {'measure': "Clinicians' experiences with ENDORISK care", 'timeFrame': 'at baseline', 'description': 'Questionnaire at baseline'}, {'measure': "Clinicians' experiences with ENDORISK care", 'timeFrame': '9 months after start of inclusions', 'description': 'Questionnaire at 9 months'}, {'measure': "Clinicians' experiences with ENDORISK care", 'timeFrame': '18 months after start of inclusions', 'description': 'Questionnaire at 18 months'}, {'measure': "Clinicians' experiences with ENDORISK care", 'timeFrame': 'Within 1 year of start of the inclusion period in their hospital.', 'description': 'In depth interviews with a sample of participating clinicians to evaluate user experiences.'}, {'measure': 'Impact of ENDORISK on regional care costs', 'timeFrame': 'from enrolment to the end of inclusions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ENDORISK', 'Endometrial Cancer', 'surgical staging', 'risk stratification', 'lymph node metastases', 'lymphadenectomy', 'sentinel node'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '35992828', 'type': 'BACKGROUND', 'citation': 'Vinklerova P, Ovesna P, Hausnerova J, Pijnenborg JMA, Lucas PJF, Reijnen C, Vrede S, Weinberger V. External validation study of endometrial cancer preoperative risk stratification model (ENDORISK). Front Oncol. 2022 Aug 3;12:939226. doi: 10.3389/fonc.2022.939226. eCollection 2022.'}, {'pmid': '32413043', 'type': 'BACKGROUND', 'citation': 'Reijnen C, Gogou E, Visser NCM, Engerud H, Ramjith J, van der Putten LJM, van de Vijver K, Santacana M, Bronsert P, Bulten J, Hirschfeld M, Colas E, Gil-Moreno A, Reques A, Mancebo G, Krakstad C, Trovik J, Haldorsen IS, Huvila J, Koskas M, Weinberger V, Bednarikova M, Hausnerova J, van der Wurff AAM, Matias-Guiu X, Amant F; ENITEC Consortium; Massuger LFAG, Snijders MPLM, Kusters-Vandevelde HVN, Lucas PJF, Pijnenborg JMA. Preoperative risk stratification in endometrial cancer (ENDORISK) by a Bayesian network model: A development and validation study. PLoS Med. 2020 May 15;17(5):e1003111. doi: 10.1371/journal.pmed.1003111. eCollection 2020 May.'}, {'pmid': '35939115', 'type': 'BACKGROUND', 'citation': 'Grube M, Reijnen C, Lucas PJF, Kommoss F, Kommoss FKF, Brucker SY, Walter CB, Oberlechner E, Kramer B, Andress J, Neis F, Staebler A, Pijnenborg JMA, Kommoss S. Improved preoperative risk stratification in endometrial carcinoma patients: external validation of the ENDORISK Bayesian network model in a large population-based case series. J Cancer Res Clin Oncol. 2023 Jul;149(7):3361-3369. doi: 10.1007/s00432-022-04218-4. Epub 2022 Aug 8.'}], 'seeAlsoLinks': [{'url': 'https://www.endorisk.eu/', 'label': 'ENDORISK website with information relating to the ENDORISK model and the research team'}]}, 'descriptionModule': {'briefSummary': "Rationale: Preoperative identification of patients at risk for lymph node metastasis (LNM) is challenging in endometrial cancer (EC). Therefore, a Bayesian network model called ENDORISK was developed and validated in three external cohorts to improve preoperative risk stratification. The next step is to implement and evaluate whether use of the model improves daily clinical practice. Objective: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate whether implementation of ENDORISK in daily clinical practice improves preoperative risk stratification. Study design: A stepped wedge non inferiority study in which two oncology regions will consecutively start implementation of ENDORISK with one year interval. The ENDORISK model will be filled in and used in preoperative treatment counselling. Results will be compared to current standard clinical care which is prospectively evaluated in both regions since March 2022 in the 'evaluation of care in endometrial cancer' study (2021-7400). Study population: all consecutive patients recently diagnosed with early stage EC who are eligible for surgical treatment, who understand Dutch and are able to fill in a digital or paper questionnaire can be included. Main study parameters/endpoints: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate implementation of ENDORISK in daily clinical practice by investigating:\n\n* The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care\n* Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care\n* Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care\n* Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care\n* Patients' and doctors' use of and experiences with the ENDORISK-model\n* Impact of ENDORISK on regional care costs"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)\n* Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* No understanding of Dutch or English language\n* Rare types of endometrial cancer, such as endometrial stroma cell sarcoma'}, 'identificationModule': {'nctId': 'NCT07200466', 'acronym': 'ENDORISK-I', 'briefTitle': 'Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'ENDORISK Clinical Implementation Study', 'orgStudyIdInfo': {'id': 'NL86300.000.24'}, 'secondaryIdInfos': [{'id': '14032', 'type': 'OTHER_GRANT', 'domain': 'Koningin Wilhelmina Fonds voor Nederlandse Kankerbestrijding'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "The control arm is a group of patients from our previous 'evaluation of care' study which underwent standard care for endometrial cancer between march of 2022 and the start of the ENDORISK-I study. This group serves as a control group for the intervention arm."}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention group are patients receiving a personalized risk on lymph node metastases as predicted by the ENDORISK model, they also receive a treatment plan (hysterectomy + bilateral salpingo-oophorectomy with or without lymph node surgery) based on this personalized risk.', 'interventionNames': ['Diagnostic Test: ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.']}], 'interventions': [{'name': 'ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.', 'type': 'DIAGNOSTIC_TEST', 'description': 'The intervention group are patients receiving a personalized risk on lymph node metastases as predicted by the ENDORISK model, they also receive a treatment plan (hysterectomy + bilateral salpingo-oophorectomy with or without lymph node surgery) based on this personalized risk.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Tijmen Bonestroo, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Doetinchem', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Kirsten Smeets, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Myrtille Vallen, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Slingeland Hospital', 'geoPoint': {'lat': 51.965, 'lon': 6.28889}}, {'city': 'Ede', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rahul Samlal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lidewij Bartelink, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hanny M.A. Pijnenborg, MD PhD', 'role': 'CONTACT', 'email': 'hanny.ma.pijnenborg@radboudumc.nl', 'phone': '+31 024 361 1111'}, {'name': 'Ruben Koek, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Berghuis - Schoenaker, Drs', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rosella Hermens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marc Snijders, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canisius Wilhelmina Ziekenhuis (CWZ)', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Winterswijk', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Charlotte Lybol, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lotte van Dijk, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Streekziekenhuis Koningin Beatrix', 'geoPoint': {'lat': 51.9725, 'lon': 6.71944}}, {'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Brenda Pijlman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Breda', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dennis van Hamont, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amphia', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dorry Boll, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Geldrop', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Channa E Schmeink, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Anna Hospital', 'geoPoint': {'lat': 51.42167, 'lon': 5.55972}}, {'city': 'Helmond', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joris van Esch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elkerliek Hospital', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Tilburg', 'state': 'North Brabant', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marieke Smink, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elisabeth-Tweesteden Hospital', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Uden', 'state': 'North Brabant', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Angèle Oei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jos Vollenbergh, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bernhoven Hospital', 'geoPoint': {'lat': 51.66083, 'lon': 5.61944}}, {'city': 'Veldhoven', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Viola Verhoef, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maxima Medical Center', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}], 'centralContacts': [{'name': 'Ruben C.G. Koek, MD / Drs', 'role': 'CONTACT', 'email': 'ruben.koek@radboudumc.nl', 'phone': '+31631015109'}, {'name': 'Hanny M.A. Pijnenborg, MD, PhD', 'role': 'CONTACT', 'email': 'hanny.ma.pijnenborg@radboudumc.nl'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'IPD will be available after the end of the study.', 'ipdSharing': 'YES', 'description': 'Only anonymized datasets (without patient numbers, date of birth or name) will be shared with other people relevant to the study or relevant to additional studies as reported in the patient information folder.\n\nPatients are requested whether or not they give permission to use anonymized data from this study for further research into cervical cancer.', 'accessCriteria': 'Researchers within the RadboudUMC will be able to get access upon request and review of research aim/protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elisabeth-TweeSteden Ziekenhuis', 'class': 'OTHER'}, {'name': 'Amphia Hospital', 'class': 'OTHER'}, {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, {'name': 'Elkerliek Hospital', 'class': 'OTHER'}, {'name': 'St. Anna Ziekenhuis, Geldrop, Netherlands', 'class': 'OTHER'}, {'name': "Jeroen Bosch Ziekenhuis, s'-Hertogenbosch", 'class': 'UNKNOWN'}, {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, {'name': 'Canisius Wilhelmina Ziekenhuis (CWZ)', 'class': 'UNKNOWN'}, {'name': 'Maxima Medical Center', 'class': 'OTHER'}, {'name': 'Bernhoven Hospital', 'class': 'OTHER'}, {'name': 'Maas Hospital Pantein', 'class': 'OTHER'}, {'name': 'Slingeland Hospital', 'class': 'OTHER'}, {'name': 'Streekziekenhuis Koningin Beatrix', 'class': 'UNKNOWN'}, {'name': 'Gelderse Vallei Hospital', 'class': 'OTHER'}, {'name': 'Comprehensive Cancer Centre The Netherlands', 'class': 'OTHER'}, {'name': 'Stichting PAMM', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}