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NCT05708599
A Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer
Conditions: Non-Small-Cell Lung Carcinoma, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 180
Sponsor: Boehringer Ingelheim
Location: Germany
Summary
In this study, liquid biopsy samples will be obtained from non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC) patients who undergo treatment according to established standards of care (SoC) at the University Hospital Schleswig-Holstein (UKSH).This study will observe the overall Variant Allele Frequency (VAF) of circulating tumour Desoxyribonucleic acid (ctDNA) levels over the patient therapeutic treatment course and will correlate these findings with tumour response, as well as Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status.
Eligibility Criteria
Inclusion Criteria:≥18 years oldMale or female patients with pancreatic ductal adenocarcinoma, colorectal carcinoma or adenocarcinoma of the lung as specified above leading to new treatment line.Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the study.Willingness to undergo pre- and on-treatment liquid biopsies for biomarker assessment.
Patients can be enrolled without tissue tumour biopsy upon agreement between the Investigator and the Sponsor.Exclusion Criteria:Patients not expected to comply with the protocol requirements or not expected to complete the study as scheduled (e.g.
chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable study participant).Women who are pregnant or who plan to become pregnant during the study.Participation at a clinical trial involving an investigational medicine.
Source: ClinicalTrials.gov (NCT05708599). StuddyBuddy aggregates publicly available trial information.