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PURPOSE: To determine the prognostic properties of a comprehensive evaluation of body composition and physical function in patients with GI-HEP cancer from point of diagnosis and throughout the treatment trajectory.
GI-HEP: Patients with tumors of the upper gastrointestinal or hepatobiliary tract, specifically tumors of the esophagus, gastro-esophageal junction, stomach, primary tumors of the liver or biliary tract, as well as colorectal liver metastasis or tumors of the pancreas.
RATIONAL: Patients diagnosed with GI-HEP cancer are faced with poor prognosis. The treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. To what extend patients body composition at the point of diagnoses, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well-described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Resectable patients | These patients will undergo 3 assessments: a baseline-assessment prior to surgery, a post-surgery assessment (2 week post-surgery) and a follow-up assessment 6 months after surgery (after adjuvant oncology treatment). | ||
| Cohort 2 - Non-resectable patients | These patients will undergoing 3 assessments: a baseline-assessment prior to palliative treatment, an acute measurement 4 weeks after initiation of palliative treatment, and a 6-month long-term assessment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Post-operative complications | Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher). | From baseline to 30 days post surgery |
| Cohort 2: Medical treatment complications | Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation) | From baseline to 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization duration | Total number days in hospital | From baseline to 1 year follow-up |
| Disease free survival | Risk of disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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GI-HEP cancer specified as tumors of the esophagus, gastroesophageal junction, stomach, primary tumors of the liver and biliary tract. As well as colorectal liver metastasis and tumors of the pancreas.
The study will include patients who are candidates for tumor resection and patients who are not candidates for surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Jesper F Christensen, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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Blood samples will be immediately analyzed for plasma biochemistry and a 10 ml plasma sample will be frozen and stored in a study specific biobank.
As an optional procedure (amendment), we will collect biological tissue from tumor (1mg), muscle (200 mg) and fat (200 mg) biopsies during surgery, from which RNA will be extracted and used to assess small RNA and gene expression by microarray technology and quantitative PCR. For the optional procedure, patients will sign additional separate informed consent before any biopsies are taken. This material will be stored in a study specific biobank until the study is completed, expected 31.12.2022
| From baseline to 1 year follow-up |
| Overall survival | Risk of mortality from any-cause | From baseline to 1 year follow-up |
| Change in whole body lean mass | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 6 months follow-up |
| Change in appendicular lean mass | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 6 months follow-up |
| Change in whole body fat percentage | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 6 months follow-up |
| Change in visceral fat mass | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 6 months follow-up |
| Change in bone mineral density | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 6 months follow-up |
| Change in bone mineral content | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 6 months follow-up |
| Change in Skeletal Muscle Index | L3 muscle area determined by Computed tomography scan (performed for clinical purpose) adjusted for hight | From baseline to 6 months follow-up |
| Change in Walking capacity | Maximum 10 meter walking speed | From baseline to 6 months follow-up |
| Change in stair-climbing capacity | Timed Stair-climbing test | From baseline to 6 months follow-up |
| Change in lower body physical function | 30 seconds Sit-To-Stand test | From baseline to 6 months follow-up |
| Change in maximum leg power | Leg extensor power test (Nottingham Power rig) | From baseline to 6 months follow-up |
| Change in hand grip strength | Maximum strength test by handgrip dynanometer | From baseline to 6 months follow-up |
| Change in plasma total cholesterol concentration | Blood sample | From baseline to 6 months follow-up |
| Change in plasma HDL cholesterol | Blood sample | From baseline to 6 months follow-up |
| Change in plasma LDL cholesterol | Blood sample | From baseline to 6 months follow-up |
| Change in plasma triglycerides | Blood sample | From baseline to 6 months follow-up |
| Change in plasma HbA1C | Blood sample | From baseline to 6 months follow-up |
| Change in plasma glucose | Blood sample | From baseline to 6 months follow-up |
| Change in plasma insulin | Blood sample | From baseline to 6 months follow-up |
| Change in health-related quality of life | Functional Assessment of Cancer Therapy (FACT) questionnaire | From baseline to 6 months follow-up |
| Change in psychological distress | Hospital Anxiety and Depression Scale (HADS) questionnaire | From baseline to 6 months follow-up |
| Change in sleep quality | Pittsburgh Sleep Quality Index (PSQI) questionnaire | From baseline to 6 months follow-up |
| Change in physical activity level | International Physical Activity Questionnaire (IPAQ) short form | From baseline to 6 months follow-up |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |