Clinical trial NCT05708599: A Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Small-Cell Lung Carcinoma
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Universitätsklinikum Kiel, Onkologisches Zentrum
First posted: 2023-02-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean variant allele frequency (VAF) of mutations in circulating tumour Desoxyribonucleic acid (ctDNA) samples over the timescale of the patient's treatment course
timeFrame: up to 5 years
Secondary outcomes:
measure: Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baseline
timeFrame: up to 5 years
measure: Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective response
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
Study officials:
References: