Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

NCT ID: NCT04922515

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-25
• Study Completion Date: 2023-12-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Oral and rectal swabs for microbiome sequencing

Oral swabs and rectal swabs are collected non-invasively.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Albrecht Neesse

https://gastroenterologie.umg.eu/ueber-uns/team/neesse/

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albrecht Neesse, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Goettingen

Locations

University Medical Centre Goettingen

Göttingen, , Germany

Site Status: RECRUITING

University Medical Centre Göttingen

Göttingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Albrecht Neesse, MD, PhD

Role: CONTACT

albrecht.neesse@med.uni-goettingen.de

0049 551 39 ext. 62313

Christoph Ammer-Herrmenau, MD

Role: CONTACT

christoph.herrmenau@med.uni-goettingen.de

Facility Contacts

Albrecht Neesse, MD, PhD

Role: primary

Volker Ellenrieder, MD

Role: primary

volker.ellenrieder@med.uni-goettingen.de

0049 551 39 ext. 62313

Other Identifiers

PDA-MAPS

Identifier Type: -

Identifier Source: org_study_id