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2013-01
2016-06-30
2016-06-30
445
NCT01753479
Olympus Corporation
Olympus Corporation
INTERVENTIONAL
Spectroscopy From Duodenum
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.
Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. The investigators would like to look at the spectroscopy technique for pancreatic cancer diagnosis via an upper endoscopy. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis. Therefore this study can be positioned as a feasibility study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-12-17 | N/A | 2017-03-03 |
2012-12-17 | N/A | 2017-03-07 |
2012-12-20 | N/A | 2017-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Test subject | OTHER: Spectroscopy device
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort | To clarify that there is the statistically-significant difference between two cohorts. | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants. | A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity. | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
