Pancreatic Ductal Adenocarcinoma – Microbiome as Predictor of Subtypes

Overview

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.

Full Title of Study: “Pancreatic Ductal Adenocarcinoma – Microbiome as Predictor of Subtypes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Progression free survival
    • Time Frame: 12 months upon study enrollment
    • Progression free survival of patients measured in months

Secondary Measures

  • Molecular subtypes of pancreatic cancer
    • Time Frame: within 3 months of histological diagnosis
    • Basal and classical subtype via RNAseq from tissue samples
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Goettingen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Albrecht Neesse, https://gastroenterologie.umg.eu/ueber-uns/team/neesse/ – University Medical Center Goettingen
  • Overall Official(s)
    • Albrecht Neesse, MD, PhD, Principal Investigator, University Medicine Goettingen
  • Overall Contact(s)
    • Albrecht Neesse, MD, PhD, 0049 551 39, albrecht.neesse@med.uni-goettingen.de

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