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

Rekrutierend

NCT-Nummer:
NCT05708599

Studienbeginn:
Februar 2023

Letztes Update:
07.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Adenocarcinoma, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Boehringer Ingelheim

Collaborator:
Universitätsklinikum Kiel, Onkologisches Zentrum

Kontakt

Boehringer Ingelheim
Kontakt:
Phone: 1-800-243-0127
E-Mail: clintriage.rdg@boehringer-ingelheim.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Universitätsklinikum Schleswig-Holstein, Campus Kiel
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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:

1. 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)

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

Geprüfte Regime

Liquid biopsy:
Liquid biopsy

Quelle: ClinicalTrials.gov