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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

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