RecruitingNot Applicable

Semmelweis Esophageal Cancer Study: Noninvasive Prognostic Parameters in Patients With Oesophageal and Esophagogastric Junction Cancer

Hungary100 participantsStarted 2024-09-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in cardiac function: cardiac MR scan

Timeframe: From enrollment to the 12th postoperative month

Changes in coronary status: coronary CT scan

Timeframe: From enrollment to the 12th postoperative month

Morbidity (early and long term) classified after Clavien-Dindo.

Timeframe: 30 days (until 31st postoperative day)

Early and late mortality

Timeframe: 90 days (until 91st postoperative day)

Length of hospital stay

Timeframe: within 45 days

Number of days spent on ICU (Intensive care unit)

Timeframe: within 45 days postoperative

Changes in physical performance: 6-minute walk test (6MWT)

Timeframe: From enrollment to the 12th postoperative month

Trial details

NCT IDNCT06713993

SponsorSemmelweis University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-09-30

Contact for this trial

Tamas Vass

+36208259039 vass.tamas@semmelweis.hu

View on ClinicalTrials.gov More Esophageal Cancer (EsC) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in cardiac function: cardiac MR scan

Timeframe: From enrollment to the 12th postoperative month

Changes in coronary status: coronary CT scan

Timeframe: From enrollment to the 12th postoperative month

Morbidity (early and long term) classified after Clavien-Dindo.

Timeframe: 30 days (until 31st postoperative day)

Early and late mortality

Timeframe: 90 days (until 91st postoperative day)

Length of hospital stay

Timeframe: within 45 days

Number of days spent on ICU (Intensive care unit)

Timeframe: within 45 days postoperative

Changes in physical performance: 6-minute walk test (6MWT)

Timeframe: From enrollment to the 12th postoperative month