CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04455282

Studienbeginn:
Februar 2021

Letztes Update:
08.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Heinrich-Heine University, Duesseldorf

Collaborator:
University Hospital of Cologne

Studienleiter

Nikolas Stoecklein, MD
Principal Investigator
Surgery, University Hospital Düsseldorf Germany

Christiane Bruns, MD
Principal Investigator
Surgery, University Hospital Cologne

Kontakt

Nikolas H Stoecklein, MD
Kontakt:
Phone: 004921181
Phone (ext.): 16399
E-Mail: Nikolas.Stoecklein@med.uni-duesseldorf.de» Kontaktdaten anzeigen

Christiane Bruns, MD
Kontakt:
E-Mail: christiane.bruns@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Mazen A Juratli, MD, PhD
Phone: +49 251 8356304
E-Mail: mazen.juratli@ukmuenster.de» Ansprechpartner anzeigen

University Hospital Cologne
Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christiane Bruns, MD
Phone: +49 221 47
Phone (ext.): 84801
E-Mail: christiane.bruns@uk-koeln.de

Raphael Stier, MD
Phone: +49 221 47
Phone (ext.): 84801
E-Mail: raphael.stier@uk-koeln.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This is an exploratory observational biomarker study. Around 20 mL of blood will be collected

from a peripheral vein and additional 40 mL from tumor draining veins. In addition, around 5

mL of lymphatic fluid will be collected from the thoracic duct, when exposed and opened

during the surgical resection. Annual blood draws (20 mL) will be performed during routine

clinical follow-up or at the time point when the patients develops a (metastatic) relapse. A

one tube protocol will be performed from each blood sample to assess CTCs and tumor derived

extracellular Vesicles (tdEVs) using CELLSEARCH® and ACCEPT

(https://github.com/LeonieZ/ACCEPT/blob/master/ACCEPT.m). In addition, tumor cells will be

enumerated by CELLSEARCH® in the lymphatic fluid. ctDNA will be extracted from plasma of each

blood collection tube and analyzed by mFAST-SeqS. If the mutational status of the primary

tumor is known, deep sequencing of ctDNA will be applied for mutation tracking at a later

time point. Tissue resected during the surgical procedure and not required for routine

pathology will be collected into a biobank (cry-conserved and formalin fixed and paraffin

embedded (FFPE).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- histologically proven adenocarcinoma of the GEJ type I and II, resectable,

non-metastatic tumor

- age ≥18

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2,

- American Society of Anesthesiologists (ASA) < 4.

- pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 GEJ type I and II adenocarcinomas can

be included. In case of stage cT4a, curative resectability has to be explicitly

verified by the local surgical investigator prior inclusion.

- Written informed consent and the ability to understand the nature of the study and the

study-related procedures and to comply with them has to be ensured.

Exclusion Criteria:

- tumors of squamous, adenosquamous or other non-adenocarcinoma histology

- patients with inoperable or metastatic GEJ type I and II adenocarcinoma, GEJ type I

and II adenocarcinoma staged cT1N0 and cT4b, GEJ type I and II cT4a evaluated as not

curatively resectable by the local surgical investigator

- unsigned informed consent

Studien-Rationale

Primary outcome:

1. Difference in CTC detection rate between peripheral and tumor draining veins. (Time Frame - 24 months):
The difference between the CTC positivity rate (≥1 CTC / 7.5 mL) in blood samples of tumor-draining veins compared to the CTC positivity rate in peripheral blood. The positivity fraction and CTC number per 7.5 mL in tumor draining veins and peripheral blood samples will be determined by CellSearch.

Secondary outcome:

1. tdEVs (Time Frame - 24 months):
1. The tdEV number per 7.5 mL determined from CellSearch images using the ACCEPT software tool and the fraction of tdEVs positive patients (a cut-off threshold will be applied)(de Wit, 2019). 2. The difference between tdEV measurement in the tumor-draining veins and the peripheral blood will be assessed.

2. ctDNA (Time Frame - 24 months):
1. The tumor allele frequency measured by the genome-wide mFAST-SeqS assay (Belic, 2015) and the fraction of patients with high tumor allele frequency will be determined. For this, a threshold of 10% tumour allele frequency will be applied to discriminate high allele frequency (>10%) from low allele frequency (≤10%) cases (Belic, 2015; de Wit, 2019). 2. The difference between ctDNA measurement in the tumor-draining veins and the peripheral blood will be assessed.

3. Clinical correlation (Time Frame - 84 months):
Correlation of any of the biomarker or in combination with clinical parameters and with patient clinical outcome (OS and RFS)

4. Dynamic Biobank (Time Frame - 24 months):
The number of tumor tissues (primary tumor, lymph node metastasis, biopsy material), isolated CELLSEARCH® CTCs and plasma/ctDNA samples generated from CIRCULATE1 and stored in the respective biobanks from the University Hospital of Cologne and from University Hospital Düsseldorf.

Quelle: ClinicalTrials.gov

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