Clinical trial · Observational
Semmelweis Esophageal Cancer Study: Noninvasive Prognostic Parameters in Patients With Oesophageal and Esophagogastric Junction Cancer
Noninvasive Testing Procedures, Role of Biomarkers and Anticancer Treatments in Esophageal and Esophagogastric Cancer Survival and Quality of Life of Patients With Cancer of the Esophageopharyngeal and Oesophageophageophageal Junction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this observational study was to gain a deeper understanding of the epidemiology of the disease in Hungary through a broad analysis of patients with new-onset esophageal-oesophageal-stomach junction tumors, and to identify key parameters that could potentially influence the outcome of the disease and are closely correlated with morbidity and mortality. The investigators' primary objective is to identify potential factors and conditions that could be influenced and modified to enhance the disease outcome. Main questions: 1. What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied? 2. What is the time course of the changes during and after treatment? 3. Which pathological parameters are associated with disease outcome and which are potential points of intervention to improve the course of the disease? Patients will undergo a detailed physical and nutritional assessment, non-invasive imaging tests and several questionnaires in addition to the usual pre- and post-operative examinations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer (EsC) | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (19)
- measure
- Changes in cardiac function: cardiac MR scan
- timeFrame
- From enrollment to the 12th postoperative month
- description
- Assessment of cardiac function by cardiac MR scan before starting treatment, after surgery and at postoperative month 12.
- measure
- Changes in coronary status: coronary CT scan
- timeFrame
- From enrollment to the 12th postoperative month
- description
- Assessment of coronary status by coronary CT scan before starting treatment, after surgery and at postoperative month 12.
- measure
- Morbidity (early and long term) classified after Clavien-Dindo.
- timeFrame
- 30 days (until 31st postoperative day)
- description
- 7-day and 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * Diagnosis of new-onset esophageal, esophagogastric junction tumor * Elective curative surgery (open/laparoscopic regardless of surgical technique) * Patients who have not yet received oncological treatment for their present disease Exclusion Criteria: * Lack of consent * Lack of cooperation * Contraindications for some studies: If MR scan is contraindicated, cardiac MR scan is not performed
References
Publications (4)
- BACKGROUNDLorusso A, Bichev D, Hogner A, Bartels P, Ballhausen A, Treese C, Biebl M, Thuss-Patience P. Prognostic Relevance of Weight and Weight Loss during Multimodal Therapy for Oesophagogastric Tumours. Curr Oncol. 2022 Apr 12;29(4):2706-2719. doi: 10.3390/curroncol29040221. PMID 35448195
- BACKGROUNDvan Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088. PMID 22646630
- BACKGROUNDSondergaard MMA, Nordsmark M, Nielsen KM, Poulsen SH. Cardiovascular Burden and Adverse Events in Patients With Esophageal Cancer Treated With Chemoradiation for Curative Intent. JACC CardioOncol. 2021 Dec 21;3(5):711-721. doi: 10.1016/j.jaccao.2021.10.002. eCollection 2021 Dec. PMID 34988480
- BACKGROUNDEads JR. Cardiovascular Concerns in the Management of Esophageal Cancer Patients. JACC CardioOncol. 2021 Dec 21;3(5):722-724. doi: 10.1016/j.jaccao.2021.11.005. eCollection 2021 Dec. PMID 34988481