Pancreatic CancerNCT03178812
Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
A study testing EUS with fine-needle aspiration of pancreatic cyst and Laboratory Blood test in people with Pancreatic Cancer, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- EUS with fine-needle aspiration of pancreatic cyst and Laboratory Blood test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2017to Jun 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with pancreatic cyst
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical
Hadera, 38100
Yael Kopelman, MD, 972-50-6246840, yaelk@hy.health.gov.il
About this study
Official title: The Role of the Cystic Fluid Interleukins 1,8, & 10 and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.
- Conditions
- Pancreatic Cancer
- Being tested
- EUS with fine-needle aspiration of pancreatic cyst, Laboratory Blood test
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS with fine-needle aspiration of pancreatic cystProcedure or surgery
EUS with fine-needle aspiration
Laboratory Blood testDiagnostic test
Laboratory Blood Test
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreatic cysts | Active comparator | Fine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels Receives: Procedure: EUS with fine-needle aspiration of pancreatic cyst |
| Healthy volunteers | Active comparator | Laboratory blood test to measure Interleukin and TNF levels Receives: Procedure: EUS with fine-needle aspiration of pancreatic cyst; Diagnostic Test: Laboratory Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels
Interleukin 1,8,10 will be measured quantitatively by an enzyme-linked immunosorbent assay. The same interleukins levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Measured: Two years
Prediction of malignant potential of pancreatic cyst by measuring TNF levels
TNF levels will be measured quantitatively by an enzyme-linked immunosorbent assay. The same TNF levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One arm containing patients with pancreatic lesion and one control group arm of healthy volunteers
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178812
- Sponsor's protocol ID
- HYMC-0018-17
- Status last verified
- Jun 2017
- First submitted
- 10 May 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Cystic Fluid Interleukins 1,8, & 10 and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
- ClinicalTrials.gov ID
- NCT03178812
- Acronym / sponsor ID
- HYMC-0018-17
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Jun 2017 (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 study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One arm containing patients with pancreatic lesion and one control group arm of healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic cysts | Active comparator | Procedure: EUS with fine-needle aspiration of pancreatic cystFine-needle aspiration (FNA) by Endoscopic Ultrasound (EUS) will collect liquid from patients' pancreatic cysts to measure their Interleukin and TNF levels |
| Healthy volunteers | Active comparator | Procedure: EUS with fine-needle aspiration of pancreatic cyst, Diagnostic Test: Laboratory Blood testLaboratory blood test to measure Interleukin and TNF levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pancreatic cyst
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EUS with fine-needle aspiration of pancreatic cystEUS with fine-needle aspiration | Procedure or surgery | Healthy volunteers, Patients with pancreatic cysts |
| Laboratory Blood testLaboratory Blood Test | Diagnostic test | Healthy volunteers |
Primary outcome
Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels
Time frame: Two years
Interleukin 1,8,10 will be measured quantitatively by an enzyme-linked immunosorbent assay. The same interleukins levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Prediction of malignant potential of pancreatic cyst by measuring TNF levels
Time frame: Two years
TNF levels will be measured quantitatively by an enzyme-linked immunosorbent assay. The same TNF levels will be measured in serum of same patients and control group. Results will enable classification of cysts to either high or low risk malignancy potential.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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?
A study testing EUS with fine-needle aspiration of pancreatic cyst and Laboratory Blood test in people with Pancreatic Cancer, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 7 Jun 2017. 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 Israel. 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 Yael Kopelman, MD (972-50-6246840, yaelk@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels (time frame: Two years). 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 7 Jun 2017.