Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Not Applicable

• Conditions: Pancreatic Cancer

• Registration Number: NCT04922515
• Lead Sponsor: University Medical Center Goettingen

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.

Study Timeline

• Study Start: 2020-04-25
• Study First Submitted: 2021-05-31
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-05
• Last Update Submitted: 2021-06-05
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free survival	12 months upon study enrollment	Progression free survival of patients measured in months

Secondary Outcome Measures

Name	Time	Method
Molecular subtypes of pancreatic cancer	within 3 months of histological diagnosis	Basal and classical subtype via RNAseq from tissue samples
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

Trial Locations

Locations (2)

University Medical Centre Goettingen; 🇩🇪 Göttingen, Germany

University Medical Centre Göttingen; 🇩🇪 Göttingen, Germany