NCT04636788

Brief Summary

This study is for the verification of biomarkers for pancreatic cancer treatment using small RNA liquid biopsy, combined with EUS-FNA tissues.

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
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

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

November 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 4, 2020

Last Update Submit

November 14, 2020

Conditions

Pancreas Adenocarcinoma

Keywords

exosomesnoRNAendoscopic ultrasoundliquid biopsy

Outcome Measures

Primary Outcomes (2)

  • senstivity

    sensitivity of exo-sRNA

    up to 8 weeks

  • specificity

    specificity of exo-sRNA to differentiate between PAAD and other benigh or malignant pancreatic occupying lesions

    up to 8 weeks

Secondary Outcomes (1)

  • survival time

    up to 18 months

Study Arms (1)

pancreatic cancer group

OTHER

pancreatic cancer, anticipated participants: 68 other pancreatic lesions including MCN, SCN, IPMN, SPN without malignant pathological finding chronic pancreatitis cholangiocarcinoma healthy control anticipated participants: 34

Procedure: Venous sampling

Interventions

Venous samplingPROCEDURE

venous sampling of 12ml

pancreatic cancer group

Eligibility Criteria

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

You may qualify if:

  • age \>18
  • pancreatic cancer patients
  • pancreatic lesions other than PAAD
  • chronic pancreatitis
  • cholangiocarcinoma

You may not qualify if:

  • diagnosed with other pathological types of cancer
  • treated with chemo/radio/surgery previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Bin Cheng, Professor

CONTACT

13986097542b.cheng@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 19, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

CN(1)