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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in cardiac function: cardiac MR scan
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lack of consent
- •Lack of cooperation
- •Contraindications for some studies: If MR scan is contraindicated, cardiac MR scan is not performed
结局指标
主要结局
Changes in cardiac function: cardiac MR scan
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 90 days (until 91st postoperative day)
7-day, 30-day and 90-day mortality of each patient will be recorded
Length of hospital stay
时间窗: within 45 days
Postoperative length of hospital stay in days.
Number of days spent on ICU (Intensive care unit)
时间窗: within 45 days postoperative
Number of days observed on ICU right after operation.
Changes in physical performance: 6-minute walk test (6MWT)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From enrollment to the 12th postoperative month
Measurement of serum IL-6 level before the start of treatment, postoperatively and at postoperative month 12.
次要结局
- 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)