Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation

Official title

ENDORISK Clinical Implementation Study

Overview

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: * The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care * Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care * Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care * Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care * Patients' and doctors' use of and experiences with the ENDORISK-model * Impact of ENDORISK on regional care costs

Interventions

• Diagnostic test ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.
  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.

Primary outcome measures

• Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care. [Time frame: from enrolment to surgery]
• Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care [Time frame: From enrolment to time of surgery]
• Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care, measured by questionnaires. [Time frame: From enrolment to 12 weeks post-operatively]

Secondary outcome measures (10)

• Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care; [Time frame: from enrolment to 5-year post surgery]
• Health related quality of life (HRQoL) compared to standard care [Time frame: 12 weeks after primary surgery]
• Health-related quality of life (HRQoL) compared to standard care [Time frame: 12 months after primary surgery]
• Treatment-related morbidity compared to standard care [Time frame: 12 weeks after primary surgery]
• Treatment related morbidity compared to standard care [Time frame: 12 months after primary surgery]
• Clinicians' experiences with ENDORISK care [Time frame: at baseline]
• Clinicians' experiences with ENDORISK care [Time frame: 9 months after start of inclusions]
• Clinicians' experiences with ENDORISK care [Time frame: 18 months after start of inclusions]
• Clinicians' experiences with ENDORISK care [Time frame: Within 1 year of start of the inclusion period in their hospital.]
• Impact of ENDORISK on regional care costs [Time frame: from enrolment to the end of inclusions]

Eligibility criteria

Inclusion criteria

• Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)
• Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)

Exclusion criteria

• Unable to give informed consent
• No understanding of Dutch or English language
• Rare types of endometrial cancer, such as endometrial stroma cell sarcoma

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Netherlands · 14 centers

• Rijnstate — Arnhem
• Slingeland Hospital — Doetinchem
• Gelderse Vallei — Ede
• Radboudumc — Nijmegen
• Canisius Wilhelmina Ziekenhuis (CWZ) — Nijmegen
• Streekziekenhuis Koningin Beatrix — Winterswijk
• Jeroen Bosch Hospital — 's-Hertogenbosch
• Amphia — Breda
• … and 6 more centers

Publications

• 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 35992828
• 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, L PMID 32413043
• 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: 10.10 PMID 35939115

Identifiers

NCT: NCT07200466 · NL86300.000.24 · 14032

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗