Pancreatic Ductal Adenocarcinoma - Microbiome as Predicto... | NCT04922515

Studies
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

NCT04922515

Sponsor

University Medical Center Goettingen

Status

Unknown status

Last Update Posted

Jun 10, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Pancreatic Cancer

Interventions

Oral and rectal swabs for microbiome sequencing

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

Jun 5, 2021

First Posted Date

Jun 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2021

Last Update Posted Date

Jun 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Albrecht Neesse, https://gastroenterologie.umg.eu/ueber-uns/team/neesse/, University Medical Center GoettingenPrincipal Investigator

Lead Sponsor

University Medical Center GoettingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral and rectal swabs for microbiome sequencing	Other	Oral swabs and rectal swabs are collected non-invasively.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival	Progression free survival of patients measured in months	12 months upon study enrollment

Secondary Outcomes

Measure	Description	Time Frame
Molecular subtypes of pancreatic cancer	Basal and classical subtype via RNAseq from tissue samples	within 3 months of histological diagnosis
Response to chemotherapy	reponse, partial response and progress according to RECIST within 6 months of therapy initiation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Albrecht Neesse, MD, PhD	Contact	0049 551 39	62313	albrecht.neesse@med.uni-goettingen.de
Christoph Ammer-Herrmenau, MD	Contact			christoph.herrmenau@med.uni-goettingen.de

Overall Officials

Name	Affiliation	Role
Albrecht Neesse, MD, PhD	University Medicine Goettingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Goettingen	Recruiting	Göttingen		37075	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided