Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes (PDA-MAPS)

University Medical Center Goettingen

Status: Unknown

Conditions: Pancreatic Cancer

Treatments: Other: Oral and rectal swabs for microbiome sequencing

Study type: Interventional

Funder types: Other

Identifiers

NCT04922515

PDA-MAPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)