NCT06497777

Brief Summary

Previous research has shown that microRNAs in the blood can serve as biomarkers for early pancreatic cancer, with potential applications including detection, differential diagnosis, and prognosis prediction of pancreatic cancer. The current primary method for detecting microRNAs is RT-qPCR, but this process requires repeated temperature cycling, which demands high precision from the equipment. As an alternative, isothermal nucleic acid amplification technology does not require expensive temperature control instruments. Our research team has developed various isothermal nucleic acid amplification strategies for microRNA sensing platforms, applied to biological sample detection. This study combines the circular strand displacement amplification strategy with DNA nanomachines to develop a fluorescence sensing platform that performs dual signal amplification at a constant temperature. It is designed to detect pancreatic cancer-related microRNAs, exploring its role and potential applications in the diagnosis of pancreatic cancer patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
Jul 2024Jun 2026

First Submitted

Initial submission to the registry

July 5, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 12, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

July 5, 2024

Last Update Submit

July 5, 2024

Conditions

Keywords

MicroRNAPancreas Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Ratio of the target microRNA in patients with and without pancreatic adenocarcinoma.

    24 hours

Study Arms (2)

Pancreatic adenocarcinoma

Pancreatic adenocarcinoma which are proven by pathology, before initiation of anti-cancer treatment.

Genetic: MicroRNA (mir-642b-3p)

Healthy control

People who do not have pancreatic disease.

Interventions

A circulating microRNA in the blood of pancreatic cancer patients.

Pancreatic adenocarcinoma

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pancreatic ductal adenocarcinoma which are proven by pathology.

You may qualify if:

  • Pancreatic ductal adenocarcinoma
  • Proven by pathology
  • Patients who have not received anti-cancer therapies

You may not qualify if:

  • Less than 20 years old
  • Unable to provide inform and consent
  • Patients who have active malignancy other than pancreatic adenocarcinoma
  • Patients who have had pancreatic cancer whose anti-cancer therapies are completed or undergoing
  • Life expectancy less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Interventions

MicroRNAs

Intervention Hierarchy (Ancestors)

RNA, AntisenseAntisense Elements (Genetics)Nucleic Acids, Nucleotides, and NucleosidesRNANucleic AcidsRNA, Small UntranslatedRNA, Untranslated

Central Study Contacts

Weng Fai Wong, Master of Science

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 12, 2024

Study Start

July 6, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

July 12, 2024

Record last verified: 2024-06

Locations