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

NCT06713993 | Recruiting

• 1 other identifier: NNGYK/18646-5/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied?
2. 2.What is the time course of the changes during and after treatment?
3. 3.Which pathological parameters are associated with disease outcome and which are potential points of intervention to improve the course of the disease?

Conditions

Esophageal Cancer (EsC)

Keywords

Esophageal cancer; heart failure; sarcopenia; malnutrition; frailty; heart function; Esophageal cancer surgery; cardiovascular abnormalities

Outcome Measures

Primary Outcomes (19)

• 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.

  From enrollment to the 12th postoperative month

• 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.

  From enrollment to the 12th postoperative month

• 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.

  30 days (until 31st postoperative day)

• Early and late mortality

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

  90 days (until 91st postoperative day)

• Length of hospital stay

  Postoperative length of hospital stay in days.

  within 45 days

• Number of days spent on ICU (Intensive care unit)

  Number of days observed on ICU right after operation.

  within 45 days postoperative

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

  6-minute walk test (6MWT) assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.

  From enrollment to the 12th postoperative month

• Changes in physical performance: hand grip strength test

  Hand grip strength test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.

  From enrollment to the 12th postoperative month

• Changes in physical performance: time up and go test

  Time up and go test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.

  From enrollment to the 12th postoperative month

• Changes in ECOG (Eastern Cooperative Oncology Group) performance status

  ECOG (Eastern Cooperative Oncology Group) performance status assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.

  From enrollment to the 12th postoperative month

• Change in nutritional status, risk of malnutrition and nutritional ability: MUST (Malnutrition Universal Screening Tool)

  Malnutrition Universal Screening Tool (MUST) score recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. 0-2: If a patient receives a score of 0, then they are at a low risk. A patient with a score of 1 is a medium risk and any patient with a score of 2 or higher is considered high risk.

  From enrollment to the 12th postoperative month

• Change in nutritional status, risk of malnutrition and nutritional ability: NRS (nutritional risk score)

  NRS (nutritional risk score) recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. From enrollment to the 12th postoperative month Score 0-3: 0: absent, 3: severe

  From enrollment to the 12th postoperative month

• Change in nutritional status, risk of malnutrition and nutritional ability Description: PG-SGA (Patient-Generated Subjective Global Assessment)score

  PG-SGA (Patient-Generated Subjective Global Assessment) score recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. The PG-SGA allows to classify nutritional status into three categories: A= well nourished; B= suspected or moderate malnutrition; and C= severe malnutrition.

  From enrollment to the 12th postoperative month

• Change in nutritional status, risk of malnutrition: Bioimpedance examination

  Bioimpedance examination recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.

  From enrollment to the 12th postoperative month

• Change in nutritional ability: swallowing test

  Swallowing test recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.

  From enrollment to the 12th postoperative month

• Change in nutritional status: myostatin level

  Measurement of myostatin level before the start of treatment, postoperatively and at postoperative month 12.

  From enrollment to the 12th postoperative month

• Change in nutritional status: IGF-1 level

  Measurement of serum IGF-1 level before the start of treatment, postoperatively and at postoperative month 12.

  From enrollment to the 12th postoperative month

• Change in nutritional status: GDF-15 level

  Measurement of serum GDF-15 level before the start of treatment, postoperatively and at postoperative month 12.

  From enrollment to the 12th postoperative month

• Change in nutritional status: IL-6 level

  Measurement of serum IL-6 level before the start of treatment, postoperatively and at postoperative month 12.

  From enrollment to the 12th postoperative month

Secondary Outcomes (8)

• Change in mental status: adherence

  From enrollment to the 12th postoperative month

• Change in cancer related fatigue

  From enrollment to the 12th postoperative month

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

  within 8 weeks, if adjuvant oncotherapy is needed

• Change in mental status: depression

  From enrollment to the 12th postoperative month

• Change in mental status: anxiety

  From enrollment to the 12th postoperative month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Lack of consent
• Lack of cooperation
• Contraindications for some studies: If MR scan is contraindicated, cardiac MR scan is not performed

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, Hungary

RECRUITING

Related Publications (4)

• Lorusso 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 BACKGROUND

• van 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 BACKGROUND

• Sondergaard 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 BACKGROUND

• Eads 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Frozen tissue, fixed tissue

MeSH Terms

Conditions

Esophageal Neoplasms; Heart Failure; Sarcopenia; Malnutrition; Frailty; Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Heart Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Tamas Vass

CONTACT

+36208259039; vass.tamas@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: December 3, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 10, 2034
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Access to the data is available to any researcher who wishes to use the results for further research (e.g. meta-analysis, sytematic review). The request must be submitted to the research coordinator in the form of a formal e-mail. Data will be provided electronically after a data sharing agreement has been signed. The statistical methods for the analyses and the results must be approved by independent review.

Locations

HU (1)