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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Lack of consent

Lack of cooperation

Contraindications for some studies: If MR scan is contraindicated, cardiac MR scan is not performed

Trial population

Patients with primary operable oesophageal and oesophagogastric junction tumours presenting to the upper gastrointestinal outpatient clinic at Semmelweis University.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Changes in cardiac function: cardiac MR scan

Assessment of cardiac function by cardiac MR scan before starting treatment, after surgery and at postoperative month 12.

Time frame
From enrollment to the 12th postoperative month
2

Changes in coronary status: coronary CT scan

Assessment of coronary status by coronary CT scan before starting treatment, after surgery and at postoperative month 12.

Time frame
From enrollment to the 12th postoperative month
3

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

7-day and 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.

Time frame
30 days (until 31st postoperative day)
4

Early and late mortality

7-day, 30-day and 90-day mortality of each patient will be recorded

Time frame
90 days (until 91st postoperative day)

Secondary outcomes

1

Change in mental status: adherence

Completion of MAS-12 (Motivation Assessment Scale) questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months The MAS-12 total score ranges from 12 to 60 (higher score indicates higher treatment adherence)

Time frame
From enrollment to the 12th postoperative month
2

Change in cancer related fatigue

Brief Fatigue Inventory (BFI) questionnaires at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months Scoring respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores are divided into 3 categories based on the average of each response categorized as mild (1-3), moderate (4-6), and severe (7-10).

Time frame
From enrollment to the 12th postoperative month
3

Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).

Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded.

Time frame
within 8 weeks, if adjuvant oncotherapy is needed
4

Change in mental status: depression

Completion of PHQ-9 (Patient Health Questionnaire-9) questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)

Time frame
From enrollment to the 12th postoperative month

Other outcomes

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