Back to resultsPancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes (PDA-MAPS)
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oral and rectal swabs for microbiome sequencing
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer
Eligibility Criteria
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
Sites / Locations
- University Medical Centre GoettingenRecruiting
- University Medical Centre GöttingenRecruiting
Outcomes
Primary Outcome Measures
Progression free survival
Progression free survival of patients measured in months
Secondary Outcome Measures
Molecular subtypes of pancreatic cancer
Basal and classical subtype via RNAseq from tissue samples
Response to chemotherapy
reponse, partial response and progress according to RECIST within 6 months of therapy initiation
Full Information
NCT ID
NCT04922515
First Posted
May 31, 2021
Last Updated
June 5, 2021
Sponsor
University Medical Center Goettingen
1. Study Identification
Unique Protocol Identification Number
NCT04922515
Brief Title
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
Acronym
PDA-MAPS
Official Title
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Oral and rectal swabs for microbiome sequencing
Intervention Description
Oral swabs and rectal swabs are collected non-invasively.
Primary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival of patients measured in months
Time Frame
12 months upon study enrollment
Secondary Outcome Measure Information:
Title
Molecular subtypes of pancreatic cancer
Description
Basal and classical subtype via RNAseq from tissue samples
Time Frame
within 3 months of histological diagnosis
Title
Response to chemotherapy
Description
reponse, partial response and progress according to RECIST within 6 months of therapy initiation
Time Frame
up to 6 months after start of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albrecht Neesse, MD, PhD
Phone
0049 551 39
Ext
62313
Email
albrecht.neesse@med.uni-goettingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Ammer-Herrmenau, MD
Email
christoph.herrmenau@med.uni-goettingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albrecht Neesse, MD, PhD
Organizational Affiliation
University Medicine Goettingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Goettingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albrecht Neesse, MD, PhD
Facility Name
University Medical Centre Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Ellenrieder, MD
Phone
0049 551 39
Ext
62313
Email
volker.ellenrieder@med.uni-goettingen.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
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