Pancreas AdenocarcinomaNCT06497777
The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer. Diagnosis of Pancreatic Cancer
An observational study of Pancreas Adenocarcinoma and MicroRNA, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreas Adenocarcinoma, MicroRNA
- What is being tested?
- MicroRNA (mir-642b-3p)
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jul 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pancreatic ductal adenocarcinoma which are proven by pathology.
Who may be able to join
- Pancreatic ductal adenocarcinoma
- Proven by pathology
- Patients who have not received anti-cancer therapies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Weng Fai Wong, Master of Science, 886-972652272, 106290@ntuh.gov.tw
About this study
Official title: The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer.
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.
- Conditions
- Pancreas Adenocarcinoma, MicroRNA
- Being tested
- MicroRNA (mir-642b-3p)
- Keywords
- MicroRNA, Pancreas Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroRNA (mir-642b-3p)Genetic
A circulating microRNA in the blood of pancreatic cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic adenocarcinoma | Pancreatic adenocarcinoma which are proven by pathology, before initiation of anti-cancer treatment. Receives: Genetic: MicroRNA (mir-642b-3p) | |
| Healthy control | People who do not have pancreatic disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the target microRNA in patients with and without pancreatic adenocarcinoma.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start6 Jul 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497777
- Sponsor's protocol ID
- 202405082RINB
- Status last verified
- Jun 2024
- First submitted
- 5 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT06497777
- Acronym / sponsor ID
- 202405082RINB
- Conditions
- Pancreas Adenocarcinoma, MicroRNA
- Keywords
- MicroRNA, Pancreas Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Jul 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic adenocarcinoma | – | Genetic: MicroRNA (mir-642b-3p)Pancreatic adenocarcinoma which are proven by pathology, before initiation of anti-cancer treatment. |
| Healthy control | – | –People who do not have pancreatic disease. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic ductal adenocarcinoma which are proven by pathology.
Key inclusion criteria (3 listed)
- Pancreatic ductal adenocarcinoma
- Proven by pathology
- Patients who have not received anti-cancer therapies
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroRNA (mir-642b-3p)A circulating microRNA in the blood of pancreatic cancer patients. | Genetic | Pancreatic adenocarcinoma |
Primary outcome
Ratio of the target microRNA in patients with and without pancreatic adenocarcinoma.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Adenocarcinoma and MicroRNA, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weng Fai Wong, Master of Science (886-972652272, 106290@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of the target microRNA in patients with and without pancreatic adenocarcinoma. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.