Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

NCT03347162 | Active Not Recruiting

• 1 other identifier: MuscleLab1.0
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Cancer of Pancreas; Cancer of Liver; Cancer of Esophagus; Cancer of Stomach; Cancer, Metastatic

Keywords

Cancer; Muscle mass; Muscle strength; Complications; Patient reported outcomes; PRO; Physical function

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (26)

• Hospitalization duration

  From baseline to 1 year follow-up

• Disease free survival

  From baseline to 1 year follow-up

• Overall survival

  From baseline to 1 year follow-up

• Change in whole body lean mass

  From baseline to 6 months follow-up

• Change in appendicular lean mass

  From baseline to 6 months follow-up

Study Arms (2)

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.

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

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.

You may qualify if:

• Patients diagnosed with histologically verified GI-HEP cancer

You may not qualify if:

• Age: \<18
• Pregnancy
• Physical or mental disabilities precluding physical testing
• Inability to read and understand Danish

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesper F Christensen, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 20, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

DK (1)