Comparing tissue and liquid biopsies in cancer patients
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
NA · Boehringer Ingelheim · NCT05708599
This study is testing if liquid biopsies, which use blood samples, are better than traditional tissue biopsies for tracking treatment responses in patients with certain types of cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim (industry) |
| Locations | 1 site (Kiel) |
| Trial ID | NCT05708599 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of liquid biopsies with traditional tissue biopsies in patients diagnosed with non-small cell lung carcinoma, colorectal cancer, and pancreatic ductal adenocarcinoma. Participants will provide liquid biopsy samples while undergoing standard treatment, allowing researchers to monitor circulating tumor DNA levels and correlate these with treatment responses and specific genetic mutations. The study is conducted at the University Hospital Schleswig-Holstein, focusing on the potential advantages of liquid biopsies in cancer management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed pancreatic ductal adenocarcinoma, colorectal carcinoma, or non-small cell lung carcinoma requiring a new treatment line.
Not a fit: Patients who are pregnant or those with conditions that may hinder compliance with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cancer monitoring and treatment personalization through improved biomarker assessment.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer monitoring, indicating a growing interest and potential in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kiel
- Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Germany (RECRUITING)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Small-Cell Lung Carcinoma, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma