NCT05171517

Brief Summary

Study objective: To describe the microflora characteristics of the pancreatic solid lesions via the tissue acquired via the endoscopic ultrasound-guided fine needle aspiration/biopsy (EUS-FNA/B). Study design: This is a prospective observational study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

December 10, 2021

Last Update Submit

May 21, 2023

Conditions

Pancreatic CarcinomaPancreatic Neuroendocrine TumorAutoimmune PancreatitisMicroflora

Keywords

pancreatic solid lesionmicroflorafine needle aspiration/biopsy

Outcome Measures

Primary Outcomes (1)

  • Microflora analysis accomplished

    successful extraction of DNA and sequencing of 16s rRNA after bioinformatical removal of potential DNA contaminations via the use of 'Decontam', and microflora result is obtained.

    within one month after EUS-FNA/B procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions.

You may qualify if:

  • Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions.
  • Age ≥ 18 years and \< 80 years.

You may not qualify if:

  • Including but not limited to: poor general conditions, severe cardiopulmonary disease, difficult to tolerate EUS examination; coagulation dysfunction; platelets \<50×10\^9/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The remaining fresh tissue after sufficient specimen collected for the diagnosis acquired via EUS-FNA/B will be stored in - 80℃ fridge.

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenoma, Islet CellAutoimmune Pancreatitis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatitis, ChronicPancreatitisAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aiming Yang, M.D.

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 29, 2021

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)