Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes (PDA-MAPS)

June 5, 2021 updated by: Albrecht Neesse, University Medical Center Goettingen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • Recruiting
        • University Medical Centre Goettingen
        • Contact:
          • Albrecht Neesse, MD, PhD
      • Göttingen, Germany, 37075
        • Recruiting
        • University Medical Centre Göttingen

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular subtypes of pancreatic cancer
Time Frame: within 3 months of histological diagnosis
Basal and classical subtype via RNAseq from tissue samples
within 3 months of histological diagnosis
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
up to 6 months after start of therapy

Collaborators and Investigators

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

Sponsor

University Medical Center Goettingen

Investigators

  • Principal Investigator: Albrecht Neesse, MD, PhD, University Medicine Goettingen

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 Major Dates

Study Start (ACTUAL)

April 25, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 5, 2021

First Posted (ACTUAL)

June 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDA-MAPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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