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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Cancer (EsC)
- Sponsor
- Semmelweis University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Changes in cardiac function: cardiac MR scan
- Status
- Recruiting
- Last Updated
- 8 days ago
Overview
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:
- What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied?
- What is the time course of the changes during and after treatment?
- 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.
Detailed Description
Detailed assessment of the baseline cardiovascular risk and status (anthropometric data, physical status assessment, psychological and quality-of-life questionnaire, questionnaires on morbidity and cancer-related fatigue, 12-lead ECG, laboratory parameters, body composition, coronary CT, echocardiography and cardiac MR scan). In addition to the conventional echocardiographic and cardiac MR parameters, the investigators also aimed to determine myocardial deformation, i.e. strain (Medis Suite QStrain) and T1 and T2 mapping values and late-type contrast enhancement and to investigate their prognostic role. To determine late-type contrast accumulation and to determine ECV (extracellular volume), patients will be given Gadovis contrast media. At the same time as the cardiac MR scan (V0 and V4), a serum blood sample will be taken from the patients, from which the markers below will be measured. These markers are proteins or molecules that potentially play an important role in the development of tumour cachexia. The investigators aim to determine the prognostic significance of these parameters. (Myostatin, IGF-1 (Insulin-like Growth Factor 1), GDF-15 (Growth Differentiation Factor 15), IL-6 (Interleukin-6). Patients are followed up for cardiovascular complications during anti-tumour treatment and are taken into care. Patients will be assessed at first presentation, after neoadjuvant treatment, immediately before surgery, in the third week after surgery and in the 3rd, 6th, 9th, 12th postoperative months. Further follow-up is done by outpatient examination, by telephone or e-mail and through the eHealth system of Hungary (EESZT) until the end of the 3rd year. Patient education: The detailed patient information leaflet was prepared by the doctors involved in the development of the protocol at Semmelweis University. Data storage and data protection: Patients enrolled in the study will be given a unique identifier after enrolment. Only this unique identifier will be used in the research record, so the record will not be directly linked to the patient. No unique identifier (name, place and date of birth, clinical triage number, social security number, ID card number, etc.) will be included in the research form. A separate, locked document will be used to link the unique identifier to the patient. The system-generated unique identifier code is recorded by the clinician on paper, complete with name, social security number and patient´s social security number, prior to the first data entry. The same document contains the patient´s informed consent for the use of the data for scientific purposes. The database and the information and consent forms, including the patient´s signature, are stored by the institute coordinators. Statistical methods: Using TIBCO Statistica™ 13.4 software, the normality of continuous variables is tested using the Kolmogorov-Szmirnov test. A two-sample t-test is used for normal distribution assuming a two-tailed distribution and a one-tailed distribution for selected variables (Mandard Score for tumour regression). For variables with non-normal distribution, a Mann-Whitney U test is used as a non-parametric test. Long-term survival data are analysed using Kaplan-Meyer analysis and log rank test.The level of significance is set at p\<0.05 Ethical requirements The research design was drawn up in accordance with current legislation and the World Medical Assotiation´s Declaration of Helsinki.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in cardiac function: cardiac MR scan
Time Frame: From enrollment to the 12th postoperative month
Assessment of cardiac function by cardiac MR scan before starting treatment, after surgery and at postoperative month 12.
Changes in coronary status: coronary CT scan
Time Frame: From enrollment to the 12th postoperative month
Assessment of coronary status by coronary CT scan before starting treatment, after surgery and at postoperative month 12.
Morbidity (early and long term) classified after Clavien-Dindo.
Time Frame: 30 days (until 31st postoperative day)
7-day and 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Early and late mortality
Time Frame: 90 days (until 91st postoperative day)
7-day, 30-day and 90-day mortality of each patient will be recorded
Length of hospital stay
Time Frame: within 45 days
Postoperative length of hospital stay in days.
Number of days spent on ICU (Intensive care unit)
Time Frame: within 45 days postoperative
Number of days observed on ICU right after operation.
Changes in physical performance: 6-minute walk test (6MWT)
Time Frame: From enrollment to the 12th postoperative month
6-minute walk test (6MWT) assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Changes in physical performance: hand grip strength test
Time Frame: From enrollment to the 12th postoperative month
Hand grip strength test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Changes in physical performance: time up and go test
Time Frame: From enrollment to the 12th postoperative month
Time up and go test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Changes in ECOG (Eastern Cooperative Oncology Group) performance status
Time Frame: From enrollment to the 12th postoperative month
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.
Change in nutritional status, risk of malnutrition and nutritional ability: MUST (Malnutrition Universal Screening Tool)
Time Frame: From enrollment to the 12th postoperative month
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.
Change in nutritional status, risk of malnutrition and nutritional ability: NRS (nutritional risk score)
Time Frame: From enrollment to the 12th postoperative month
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
Change in nutritional status, risk of malnutrition and nutritional ability Description: PG-SGA (Patient-Generated Subjective Global Assessment)score
Time Frame: From enrollment to the 12th postoperative month
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.
Change in nutritional status, risk of malnutrition: Bioimpedance examination
Time Frame: From enrollment to the 12th postoperative month
Bioimpedance examination recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
Change in nutritional ability: swallowing test
Time Frame: From enrollment to the 12th postoperative month
Swallowing test recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
Change in nutritional status: myostatin level
Time Frame: From enrollment to the 12th postoperative month
Measurement of myostatin level before the start of treatment, postoperatively and at postoperative month 12.
Change in nutritional status: IGF-1 level
Time Frame: From enrollment to the 12th postoperative month
Measurement of serum IGF-1 level before the start of treatment, postoperatively and at postoperative month 12.
Change in nutritional status: GDF-15 level
Time Frame: From enrollment to the 12th postoperative month
Measurement of serum GDF-15 level before the start of treatment, postoperatively and at postoperative month 12.
Change in nutritional status: IL-6 level
Time Frame: From enrollment to the 12th postoperative month
Measurement of serum IL-6 level before the start of treatment, postoperatively and at postoperative month 12.
Secondary Outcomes
- 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)
- Change in frailty: Clinical frailty scale (CFS)(From enrollment to the 12th postoperative month)
- Change in frailty: FRAIL scale(From enrollment to the 12th postoperative month)
- Change in frailty: 5-item Frailty Score(From enrollment to the 12th postoperative month)