A monocenter registry study to document clinical, biological and quality of life parameters in patients with gastrointestinal tumors

Recruiting

• Conditions: C15-C26; Gastrointestinal tumorsCUP-SYNDROM; C80; Malignant neoplasms of digestive organs; Malignant neoplasm, without specification of site

• Registration Number: DRKS00018788
• Lead Sponsor: SLK-Kliniken Heilbronn GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with advanced GI Tumor or CUP Syndrome and indication of systemic treatment
• Molecular examination indicated
• Age =18 Jahre
• Written informed consent

Exclusion Criteria

• Severe neurologic or psychiatric disorders which interfere with the patient's ability to provide informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Overall Survival between patients who received a molecular-stratified therapy after first tumor progression at latest and patients who did not.

Secondary Outcome Measures

Name	Time	Method
- Comparison of PFS with molecular-stratified therapy and preceding therapy (PFS-Ratio)<br>- Evaluation of efficacy of therapies with pre-defined parameters<br>- Evaluation of Tumor board decisions<br>- Development of a molecular map based on NGS analyses, sub-typing of molecular signalling pathways<br>- Correlation between mutational status and clinical parameters resp. quality of life<br>- Identification of prognostic and predictive factors