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


2023-03-01


2027-12-07


2027-12-07


96

Study Overview

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.

N/A

  • Non-Small-Cell Lung Carcinoma
  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma
  • DIAGNOSTIC_TEST: Liquid biopsy
  • 0352-2187

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-01-16  

N/A  

2025-06-09  

2023-01-24  

N/A  

2025-06-11  

2023-02-01  

N/A  

2025-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Patients with early-stage and advanced-stage disease per indication

Indications: Pancreatic ductal adenocarcinoma (PDAC), colorectal carcinoma (CRC) and non-small cell lung cancer (NSCLC)

DIAGNOSTIC_TEST: Liquid biopsy

  • Liquid biopsy
Primary Outcome MeasuresMeasure DescriptionTime Frame
Mean variant allele frequency (VAF) of mutations in circulating tumour Desoxyribonucleic acid (ctDNA) samples over the timescale of the patient's treatment courseup to 5 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baselineup to 5 years
Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective responseup to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Universitätsklinikum Kiel, Onkologisches Zentrum

  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available