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NCT Number: NCT05708599

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • Male 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 where the treatment details cannot be disclosed.

Treatment and study plan

Liquid Biopsy

Diagnostic Test

Liquid biopsy

Primary outcomes

  1. Mean variant allele frequency (VAF) of mutations in circulating tumour Desoxyribonucleic acid (ctDNA) samples over the timescale of the patient's treatment course

    Time frame: up to 5 years

Secondary outcomes

  1. Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baseline

    Time frame: up to 5 years

  2. Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective response

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • University Hospital Schleswig-Holstein

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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