Pancreatic Ductal Adenocarcinoma - Microbiome As Predictor Of Subtypes

Study Overview

Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

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.

Pancreatic Cancer

OTHER: Oral and rectal swabs for microbiome sequencing

PDA-MAPS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-06-05
First Submitted that Met QC Criteria 2021-06-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-06-10
First Posted (ACTUAL) 2021-06-10	Results First Posted N/A	Last Verified 2021-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Progression free survival	Progression free survival of patients measured in months	12 months upon study enrollment

Secondary Outcome Measures	Measure Description	Time Frame
Molecular subtypes of pancreatic cancer	Basal and classical subtype via RNAseq from tissue samples	within 3 months of histological diagnosis
Response to chemotherapy	reponse, partial response and progress according to RECIST within 6 months of therapy initiation	up to 6 months after start of therapy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Albrecht Neesse, MD, PhD

Phone Number: 0049 551 39

Email: albrecht.neesse@med.uni-goettingen.de

Study Contact Backup

Name: Christoph Ammer-Herrmenau, MD

Phone Number:

Email: christoph.herrmenau@med.uni-goettingen.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

< 18 years
patients that cannot give informed consent
pregnant and breastfeeding women

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Albrecht Neesse, MD, PhD, University Medicine Goettingen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record