PancreaticNCT06108531
Tumor Exosome Liquid Biopsy Strategy to Diagnose Pancreatic Cancer
An observational study of Pancreatic, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is an observational study of patients diagnosed with pancreatic cancer by pathology, with a control group of patients with pathology suggestive of benign pancreatic lesions and normal subjects, and the diagnostic ability of exosomes to identify patients with pancreatic cancer was assessed through the detection of… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Aug 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases will be patients with newly diagnosed pancreatic cancer. Controls will be selected from patients with pancreatitis in the same hospital as the cases, matched by sex, race and age (1:1). A total of 400 patients with gallbladder cancer will be recruited.
Who may be able to join
- Diagnosis of pancreatic cancer confirmed by imaging (case) Diagnosis of chronic pancreatitis confirmed by imaging (hospital control)
Who cannot join
- The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 20092
About this study
Official title: Study on the Application of Tumor Exosome Liquid Biopsy in the Early Diagnosis of Pancreatic Cancer
This is an observational study of patients diagnosed with pancreatic cancer by pathology, with a control group of patients with pathology suggestive of benign pancreatic lesions and normal subjects, and the diagnostic ability of exosomes to identify patients with pancreatic cancer was assessed through the detection of exosomes in the peripheral blood.
- Conditions
- Pancreatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| pancreatic patients | Cases will be the patients with newly-diagnosed pancreatic. | |
| The controls | Controls will be selected from patients with pancreatitis from the same hospital as the case, matched by gender, race and age (1:1). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of proteins in tumor exosomes from patients with pancreatic cancer
We will select specific protein A from circulating exosomes of pancreatic cancer patients for further analysis.
Measured: Up to 2 years from start of study
The expression of protein A in the circulating exosomes from patients
By detecting the expression of protein A in circulating exosomes of patients. the ROC curve of A+ circulating exosomes will be compared to clinical standard tumor biomarkers (e.g., CA199) in pancreatic cancer patients.
Measured: Up to 2 years from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108531
- Sponsor's protocol ID
- IIT-2023-0118
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of Tumor Exosome Liquid Biopsy in the Early Diagnosis of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06108531
- Acronym / sponsor ID
- IIT-2023-0118
- Conditions
- Pancreatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 31 Oct 2023 (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.
This is an observational study of patients diagnosed with pancreatic cancer by pathology, with a control group of patients with pathology suggestive of benign pancreatic lesions and normal subjects, and the diagnostic ability of exosomes to identify patients with pancreatic cancer was assessed through the detection of exosomes in the peripheral blood.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatic patients | – | –Cases will be the patients with newly-diagnosed pancreatic. |
| The controls | – | –Controls will be selected from patients with pancreatitis from the same hospital as the case, matched by gender, race and age (1:1). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be patients with newly diagnosed pancreatic cancer. Controls will be selected from patients with pancreatitis in the same hospital as the cases, matched by sex, race and age (1:1). A total of 400 patients with gallbladder cancer will be recruited.
Key inclusion criteria (1 listed)
- Diagnosis of pancreatic cancer confirmed by imaging (case) Diagnosis of chronic pancreatitis confirmed by imaging (hospital control)
Key exclusion criteria (1 listed)
- The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases
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 |
|---|---|---|
| Other | The controls, pancreatic patients |
Primary outcome
Characterization of proteins in tumor exosomes from patients with pancreatic cancer
Time frame: Up to 2 years from start of study
We will select specific protein A from circulating exosomes of pancreatic cancer patients for further analysis.
The expression of protein A in the circulating exosomes from patients
Time frame: Up to 2 years from start of study
By detecting the expression of protein A in circulating exosomes of patients. the ROC curve of A+ circulating exosomes will be compared to clinical standard tumor biomarkers (e.g., CA199) in pancreatic cancer patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 inclusion and 1 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 31 Oct 2023. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of proteins in tumor exosomes from patients with pancreatic cancer (time frame: Up to 2 years from start of study). The study lists 2 primary outcomes in all. 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 31 Oct 2023.