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Trial Title:
A Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer
NCT ID:
NCT05708599
Condition:
Non-Small-Cell Lung Carcinoma
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Carcinoma
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Liquid biopsy
Description:
Liquid biopsy
Arm group label:
Patients with early-stage and advanced-stage disease per indication
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Start date:
February 7, 2023
Completion date:
February 7, 2028
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Collaborator:
Agency:
Universitätsklinikum Kiel, Onkologisches Zentrum
Agency class:
Other
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05708599
https://www.mystudywindow.com