Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Pancreatic Cancer Clinical Trial

— PDA-MAPS  

Official title:

Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922515
• Other study ID #: PDA-MAPS
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: University Medical Center Goettingen
• Contact: Albrecht Neesse, MD, PhD
• Phone: 0049 551 39
• Email: albrecht.neesse[@]med.uni-goettingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer

Intervention

Other:
• Oral and rectal swabs for microbiome sequencing
Oral swabs and rectal swabs are collected non-invasively.

Locations

Country	Name	City	State
Germany	University Medical Centre Goettingen	Göttingen
Germany	University Medical Centre Göttingen	Göttingen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Progression free survival of patients measured in months	12 months upon study enrollment
Secondary	Molecular subtypes of pancreatic cancer	Basal and classical subtype via RNAseq from tissue samples	within 3 months of histological diagnosis
Secondary	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