Endometrial Cancer
Conditions
Keywords
ENDORISK, Endometrial Cancer, surgical staging, risk stratification, lymph node metastases, lymphadenectomy, sentinel node
Brief summary
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_TESTENDORISK 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.
Sponsors
Radboud University Medical Center
Elisabeth-TweeSteden Ziekenhuis
Amphia Hospital
Catharina Ziekenhuis Eindhoven
Elkerliek Hospital
St. Anna Ziekenhuis, Geldrop, Netherlands
Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
Rijnstate Hospital
Canisius-Wilhelmina Hospital
Maxima Medical Center
Bernhoven Hospital
Maas Hospital Pantein
Slingeland Hospital
Streekziekenhuis Koningin Beatrix
Gelderse Vallei Hospital
Comprehensive Cancer Centre The Netherlands
Stichting PAMM
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care. | from enrolment to surgery | — |
| Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care | From enrolment to time of surgery | 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. |
| Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care, measured by questionnaires. | From enrolment to 12 weeks post-operatively | Information provision score: Questionnaire EORTC Quality of Life Questionnaire (QLQ)-INFO25 with additional questions specific to ENDORISK use. Shared-decision making score: Shared Decision Making Questionnaire SDM-Q-9 with additional questions specific to ENDORISK use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care; | from enrolment to 5-year post surgery | — |
| Health related quality of life (HRQoL) compared to standard care | 12 weeks after primary surgery | as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30 |
| Health-related quality of life (HRQoL) compared to standard care | 12 months after primary surgery | as measured by questionnaire: EORTC QLQ-C30 |
| Treatment-related morbidity compared to standard care | 12 weeks after primary surgery | As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24 |
| Treatment related morbidity compared to standard care | 12 months after primary surgery | As measured by questionnaire: EORTC QLQ-EN24 and questionnaires about lymphoedema: EORTC IL76 \& Lymphoedema quality of Life (LYMQOL) |
| Clinicians' experiences with ENDORISK care | at baseline | Questionnaire at baseline |
| Impact of ENDORISK on regional care costs | from enrolment to the end of inclusions | — |
Countries
Netherlands
Contacts
CONTACTRuben C.G. Koek, MD / Drs
CONTACTHanny M.A. Pijnenborg, MD, PhD
Outcome results
None listed