A Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer

Longitudinal Liquid Biopsy Study Without an Investigational Medicinal Product in Patients With Non-Small Cell Lung Cancer (NSCLC) Including Squamous Cell Carcinoma, Adenocarcinoma and Large Cell Carcinoma, Colorectal Carcinoma (CRC) and Pancreatic Ductal Adenocarcinoma (PDAC) to Evaluate Novel Blood-based Biomarkers for Use in Early Clinical Development

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05708599

Enrollment

102

Registered

2023-02-01

Start date

2023-03-01

Completion date

2027-02-08

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Non-Small-Cell Lung Carcinoma, Pancreatic Ductal Adenocarcinoma

Brief summary

In study, liquid biopsy samples will be obtained from non-small cell lung cancer (NSCLC) including Squamous cell carcinoma, Adenocarcinoma and large cell carcinoma, 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.

Interventions

DIAGNOSTIC_TESTLiquid biopsy

Liquid biopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. ≥18 years old 2. Male or female patients with pancreatic ductal adenocarcinoma, colorectal carcinoma or adenocarcinoma of the lung as specified above leading to new treatment line. 3. 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. 4. 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

1. 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). 2. Women who are pregnant or who plan to become pregnant during the study. 3. Participation at a clinical trial involving an investigational medicine where the treatment details cannot be disclosed.

Design outcomes

Primary

Measure	Time frame
Mean variant allele frequency (VAF) of mutations in circulating tumour Desoxyribonucleic acid (ctDNA) samples over the timescale of the patient's treatment course	up to 5 years

Secondary

Measure	Time frame
Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baseline	up to 5 years
Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective response	up to 5 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026