Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation
A legfontosabb adatok
- Hol
- 's-Hertogenbosch, Arnhem, Breda, Doetinchem, Ede, Eindhoven, Geldrop, Helmond, Nijmegen, Tilburg, Uden, Veldhoven és Winterswijk (Hollandia)Mind a 14 helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
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A vizsgálat olyan nőket keres, akiknél nemrég korai stádiumú méhtestrákot diagnosztizáltak, és akik elsődleges kezelésként műthetők.
- Életkor
- 45 éves vagy idősebb
- Nem
- Csak nők
- A betegség stádiuma
- Korai stádiumú (FIGO I-II. stádium) méhtestrák, bármilyen grádusszal
- Korábbi kezelés
- Elsődleges kezelésként műthetőnek kell lennie; a műtét előtti kezelés (neoadjuváns terápia) megengedett
A részvétel fő kizáró okai
- Nem tud beleegyező nyilatkozatot adni
- Nem érti a holland vagy az angol nyelvet
- A méhtestrák ritka típusai, például az endometrium stroma sejtes szarkóma
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Hollandia
- Jeroen Bosch Hospital's-Hertogenbosch, HollandiaContact: Louis van der Putten, MD PhD (principal investigator)Résztvevőt keres
- RijnstateArnhem, HollandiaContact: Tijmen Bonestroo, MD PhD (principal investigator)Résztvevőt keres
- AmphiaBreda, HollandiaContact: Dennis van Hamont, MD PhD (principal investigator)Résztvevőt keres
- Slingeland HospitalDoetinchem, HollandiaContact: Kirsten Smeets, MD (sub-investigator)Toborzás még nem indult
- Gelderse ValleiEde, HollandiaContact: Rahul Samlal, MD (principal investigator)Résztvevőt keres
- Catharina hospitalEindhoven, HollandiaContact: Dorry Boll, MD PhD (principal investigator)Résztvevőt keres
- St. Anna HospitalGeldrop, HollandiaContact: Channa E Schmeink, MD PhD (principal investigator)Résztvevőt keres
- Elkerliek HospitalHelmond, HollandiaContact: Joris van Esch, MD (principal investigator)Résztvevőt keres
- Canisius Wilhelmina Ziekenhuis (CWZ)Nijmegen, HollandiaContact: Willem Jan van Weelden, MD PhD (principal investigator)Toborzás még nem indult
- RadboudumcNijmegen, HollandiaContact: Hanny M.A. Pijnenborg, MD PhDRésztvevőt keres
- Elisabeth-TweeSteden HospitalTilburg, HollandiaContact: Marieke Smink, MD (principal investigator)Résztvevőt keres
- Bernhoven HospitalUden, HollandiaContact: Angèle Oei, MD (principal investigator)Résztvevőt keres
- Maxima Medical CenterVeldhoven, HollandiaContact: Viola Verhoef, MD PhD (principal investigator)Résztvevőt keres
- Streekziekenhuis Koningin BeatrixWinterswijk, HollandiaContact: Charlotte Lybol, MD PhD (principal investigator)Toborzás még nem indult
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Radboud University Medical Center
- Azonosító
- NCT07200466
- A regiszteradat frissítve
- 2026. július 29.
- Eredeti leírás
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:A teljes eredeti leírásKevesebb
ENDORISK Clinical Implementation Study
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
Bevonási feltételek: Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted); Eligible for primary surgical treatment (neo-adjuvant therapy is permitted).
Kizáró feltételek: Rare types of endometrial cancer, such as endometrial stroma cell sarcoma; Unable to give informed consent; No understanding of Dutch or English language.