NCT05043532

Brief Summary

This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

September 7, 2021

Last Update Submit

January 11, 2023

Conditions

Pancreatic CancerPancreatic NeoplasmsAdenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

  • Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy

    Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy

    7 days

Secondary Outcomes (4)

  • Number of actionable mutations detected on molecular profiling

    7 days

  • Rate of technical success

    1 day

  • Rate of procedure-related adverse events

    7 days

  • Type of actionable mutations detected on molecular profiling

    7 days

Study Arms (2)

Two passes performed during EUS-FNB of pancreatic adenocarcinoma

ACTIVE COMPARATOR

Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.

Procedure: 2 passes during EUS-guided fine needle biopsy

Three passes performed during EUS-FNB of pancreatic adenocarcinoma

ACTIVE COMPARATOR

Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.

Procedure: 3 passes during EUS-guided fine needle biopsy

Interventions

2 passes during EUS-guided fine needle biopsyPROCEDURE

Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.

Two passes performed during EUS-FNB of pancreatic adenocarcinoma
3 passes during EUS-guided fine needle biopsyPROCEDURE

Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.

Three passes performed during EUS-FNB of pancreatic adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and over
  • Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy

You may not qualify if:

  • Age \< 18 years
  • Females who are pregnant
  • Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
  • Biopsied pancreatic mass is not adenocarcinoma on pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ji Young Bang, MD MPH

    Orlando Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patient undergoing the procedure, research coordinator calling patients for follow-up and the pathologist performing molecular profiling will be blinded to the randomization group.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 14, 2021

Study Start

August 18, 2021

Primary Completion

March 1, 2023

Study Completion

June 30, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)