Pancreatic Cancer
Conditions
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.
Interventions
OTHEROral and rectal swabs for microbiome sequencing
Oral swabs and rectal swabs are collected non-invasively.
Sponsors
University Medical Center Goettingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 12 months upon study enrollment | Progression free survival of patients measured in months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactAlbrecht Neesse, MD, PhD
Backup ContactChristoph Ammer-Herrmenau, MD
Outcome results
None listed