Detection and Monitoring of Gastrointestinal Cancer and Cancer Recurrence by laser-based infrared Molecular Fingerprinting

Recruiting

• Conditions: C25; C22.1; C22.0; C18; Malignant neoplasm of pancreas; Intrahepatic bile duct carcinoma; Liver cell carcinoma; Malignant neoplasm of colon

• Registration Number: DRKS00028668
• Lead Sponsor: udwig-Maximilians Universität München, Fakultät für Physik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adults > 18 years who are able to consent to this study
• Patient has consented to this study
• Resectable gastrointestinal tumor such as liver cancer, colorectal cancer, cholangiocellular adenocarcinoma and pancreatic cancer
• In the case of HCC and/or liver cirrhosis Child-Pugh class A or B. Only patients with Child-Pugh index class B of not more than 7 will be included
• Life expectancy of 12 weeks or more

Exclusion Criteria

• Patients unable to consent
• Pregnant and breastfeeding women
• Tumor or tumortherapy within the last 2 years
• Multiple cancers
• Renal failure requiring hemo- or peritoneal dialysis.
• In the case of HCC and/or liver cirrhosis Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area underneath the receiver operating characteristic function (AUC) of spectral features (GMFs) for discriminating blood samples of patients with confirmed liver cancer, colorectal cancer, cholangiocellular adenocarcinoma and pancreatic cancer. Spectral features are derived using laser-based infrared spectrosopy.

Secondary Outcome Measures

Name	Time	Method
• Proteomic profiles from mass spectrometry of blood samples of patients with confirmed liver cancer, colorectal cancer, cholangiocellular adenocarcinoma and pancreatic cancer<br>• Routine clinical data, including medical imaging data and currently used biomarkers, of patients with confirmed liver cancer, colorectal cancer, cholangiocellular adenocarcinoma and pancreatic cancer.