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Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Rekrutierend

NCT-Nummer:
NCT04922515

Studienbeginn:
April 2020

Letztes Update:
10.06.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Medical Center Goettingen

Collaborator:
-

Studienleiter

Albrecht Neesse, MD, PhD
Principal Investigator
University Medicine Goettingen

Kontakt

Albrecht Neesse, MD, PhD
Kontakt:
Phone: 0049 551 39
Phone (ext.): 62313
E-Mail: albrecht.neesse@med.uni-goettingen.de» Kontaktdaten anzeigen

Christoph Ammer-Herrmenau, MD
Kontakt:
E-Mail: christoph.herrmenau@med.uni-goettingen.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

University Medical Centre Goettingen
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Albrecht Neesse, MD, PhD» Ansprechpartner anzeigen

University Medical Centre Göttingen
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Volker Ellenrieder, MD
Phone: 0049 551 39
Phone (ext.): 62313
E-Mail: volker.ellenrieder@med.uni-goettingen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as

Predictor of Subtypes" aims to investigate the prognostic and predictive power of the

orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic,

transcriptional and clinical data, in particular with treatment response. Patients with

histologically confirmed PDA are enrolled at primary diagnosis and prior to oncological or

surgical treatment. Rectal and buccal microbiome swabs as well as detailed clinical records

are obtained from all patients. Following DNA extraction, both 16S rRNA and metagenomic

sequencing will be performed using ONT sequencing platform. All data and clinical records are

centrally stored, visualized and integrated via tranSMART and SEEK platforms.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients with pancreatic mass suspicious of pancreatic ductal adenocarcinoma

Exclusion Criteria:

- < 18 years

- patients that cannot give informed consent

- pregnant and breastfeeding women

Studien-Rationale

Primary outcome:

1. Progression free survival (Time Frame - 12 months upon study enrollment):
Progression free survival of patients measured in months

Secondary outcome:

1. Molecular subtypes of pancreatic cancer (Time Frame - within 3 months of histological diagnosis):
Basal and classical subtype via RNAseq from tissue samples

2. Response to chemotherapy (Time Frame - up to 6 months after start of therapy):
reponse, partial response and progress according to RECIST within 6 months of therapy initiation

Geprüfte Regime

Oral and rectal swabs for microbiome sequencing:
Oral swabs and rectal swabs are collected non-invasively.

Quelle: ClinicalTrials.gov