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

Not Applicable

Recruiting

• Conditions: Non-Small-Cell Lung Carcinoma; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer
• Interventions: Diagnostic Test: Liquid biopsy

• Registration Number: NCT05708599
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-01
• Study Start: 2023-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14
• Primary Completion: 2028-02-07
• Study Completion: 2028-02-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with early-stage and advanced-stage disease per indication	Liquid biopsy	Indications: Pancreatic ductal adenocarcinoma (PDAC), colorectal carcinoma (CRC) and non-small cell lung cancer (NSCLC)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany