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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05708599
Collaborator
Universitätsklinikum Kiel, Onkologisches Zentrum (Other)
180
Enrollment
1
Arm
60.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this study, liquid biopsy samples will be obtained from non-small cell lung cancer (NSCLC), 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Liquid biopsy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Longitudinal Liquid Biopsy Study Without an Investigational Medicinal Product in Patients With Non-Small Cell Lung Cancer (NSCLC), Colorectal Carcinoma (CRC) and Pancreatic Ductal Adenocarcinoma (PDAC) to Evaluate Novel Blood-based Biomarkers for Use in Early Clinical Development
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Feb 7, 2028
Anticipated Study Completion Date :
Feb 7, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with early-stage and advanced-stage disease per indication

Indications: Pancreatic ductal adenocarcinoma (PDAC), colorectal carcinoma (CRC) and non-small cell lung cancer (NSCLC)

Diagnostic Test: Liquid biopsy
Liquid biopsy

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Tumour growth/tumour marker changes for each therapeutic treatment regimen at each biopsy sampling time point as compared to baseline [up to 5 years]

  2. Correlation of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation status and objective response [up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim
  • Universitätsklinikum Kiel, Onkologisches Zentrum

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05708599
Other Study ID Numbers:
  • 0352-2187
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 1, 2023