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

Официальное название

ENDORISK Clinical Implementation Study

Обзор

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

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care. [Срок оценки: from enrolment to surgery]
• Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care [Срок оценки: 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. [Срок оценки: From enrolment to 12 weeks post-operatively]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 14 центров

• 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
• … и ещё 6 центров

Публикации

• 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

Идентификаторы

NCT: NCT07200466 · NL86300.000.24 · 14032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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