Back to resultsA Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer
Primary Purpose
Non-Small-Cell Lung Carcinoma, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Liquid biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Non-Small-Cell Lung Carcinoma
Eligibility Criteria
Inclusion Criteria: ≥18 years old Male or female patients with pancreatic ductal adenocarcinoma, colorectal carcinoma or adenocarcinoma of the lung as specified above leading to new treatment line. 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. 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: 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). Women who are pregnant or who plan to become pregnant during the study. Participation at a clinical trial involving an investigational medicine where the treatment details cannot be disclosed.
Sites / Locations
- Universitätsklinikum Schleswig-Holstein, Campus KielRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with early-stage and advanced-stage disease per indication
Arm Description
Indications: Pancreatic ductal adenocarcinoma (PDAC), colorectal carcinoma (CRC) and non-small cell lung cancer (NSCLC)
Outcomes
Primary Outcome Measures
Mean variant allele frequency (VAF) of mutations in circulating tumour Desoxyribonucleic acid (ctDNA) samples over the timescale of the patient's treatment course
Secondary Outcome Measures
Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baseline
Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective response
Full Information
NCT ID
NCT05708599
First Posted
January 16, 2023
Last Updated
August 4, 2023
Sponsor
Boehringer Ingelheim
Collaborators
Universitätsklinikum Kiel, Onkologisches Zentrum
1. Study Identification
Unique Protocol Identification Number
NCT05708599
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
February 7, 2028 (Anticipated)
Study Completion Date
February 7, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Universitätsklinikum Kiel, Onkologisches Zentrum
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with early-stage and advanced-stage disease per indication
Arm Type
Experimental
Arm Description
Indications: Pancreatic ductal adenocarcinoma (PDAC), colorectal carcinoma (CRC) and non-small cell lung cancer (NSCLC)
Intervention Type
Diagnostic Test
Intervention Name(s)
Liquid biopsy
Intervention Description
Liquid biopsy
Primary Outcome Measure Information:
Title
Mean variant allele frequency (VAF) of mutations in circulating tumour Desoxyribonucleic acid (ctDNA) samples over the timescale of the patient's treatment course
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baseline
Time Frame
up to 5 years
Title
Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective response
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years old
Male or female patients with pancreatic ductal adenocarcinoma, colorectal carcinoma or adenocarcinoma of the lung as specified above leading to new treatment line.
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.
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:
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).
Women who are pregnant or who plan to become pregnant during the study.
Participation at a clinical trial involving an investigational medicine where the treatment details cannot be disclosed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Links:
URL
https://www.mystudywindow.com
Description
Related Info
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A Study to Compare Tissue and Liquid Biopsies in People With Different Types of Cancer
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