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PDA-MAPS: Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Sponsor
University Medical Center Goettingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04922515
Collaborator
(none)
200
Enrollment
2
Locations
44.2
Anticipated Duration (Months)
100
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oral and rectal swabs for microbiome sequencing
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
Actual Study Start Date :
Apr 25, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Progression free survival [12 months upon study enrollment]

    Progression free survival of patients measured in months

Secondary Outcome Measures

  1. Molecular subtypes of pancreatic cancer [within 3 months of histological diagnosis]

    Basal and classical subtype via RNAseq from tissue samples

  2. Response to chemotherapy [up to 6 months after start of therapy]

    reponse, partial response and progress according to RECIST within 6 months of therapy initiation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Centre Goettingen Göttingen Germany 37075
2 University Medical Centre Göttingen Göttingen Germany 37075

Sponsors and Collaborators

  • University Medical Center Goettingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Albrecht Neesse, https://gastroenterologie.umg.eu/ueber-uns/team/neesse/, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT04922515
Other Study ID Numbers:
  • PDA-MAPS
First Posted:
Jun 10, 2021
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenocarcinoma

Study Results

No Results Posted as of Jun 10, 2021