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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708599
• Other study ID #: 0352-2187
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: February 7, 2028

Study information

• Verified date: August 2023
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 7, 2028
• Est. primary completion date: February 7, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Liquid biopsy
Liquid biopsy

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Universitätsklinikum Kiel, Onkologisches Zentrum

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

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