Spectroscopy From Duodenum
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Purpose
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.
| Condition | Intervention |
|---|---|
|
Pancreatic Adenocarcinoma |
Other: Spectroscopy device |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Duodenal Spectroscopy Study for Cancer Diagnosis |
- The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]To clarify that there is the statistically-significant difference between two cohorts.
- The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants. [ Time Frame: 1 year ] [ Designated as safety issue: No ]A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Test subject |
Other: Spectroscopy device
Spectrum data are collected using spectroscopy device via an instrumental channel of endoscope. Then spectrum data is analyzed. Numerical features (spectral slope and width of spectrum) are used for statistical analysis.
|
Detailed Description:
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 techniquie 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Common inclusion criterion
- Age is 18 years or older.
- Informed consent was obtained.
- Inclusion criterion for normal cohort
- An upper GI endoscopy is scheduled to check upper abdominal symptoms.
- No findings of pancreatic disorder as documented by CT or MRI or EUS
- Inclusion criterion for PC suspicious cohort * A EUS or ERCP is scheduled to suspected pancreatic disorder.
Exclusion Criteria:
Common exclusion criterion
- Severe cardiac disease
- Severe respiratory disease
- Bleeding disorders
- Pregnancy
Contacts and Locations| Contact: Michael B Wallace, M.D. | (904)953-7382 | Wallace.Michael@mayo.edu |
| United States, Florida | |
| Mayo Clinic Florida | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Michael B Wallace, M.D. 904-953-7382 Wallace.Michael@mayo.edu | |
| United States, Texas | |
| The University of Texas M. D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States | |
| Belgium | |
| Hôpital Erasme | Recruiting |
| Bruxelles, Belgium | |
| Italy | |
| Università Cattolica del Sacro Cuore | Recruiting |
| Rome, Italy | |
| Principal Investigator: | Michael B Wallace, M.D. | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Olympus Medical Systems Corporation |
| ClinicalTrials.gov Identifier: | NCT01753479 History of Changes |
| Other Study ID Numbers: | OMSC-Mag-1 |
| Study First Received: | December 17, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Borad |
Keywords provided by Olympus Medical Systems Corporation:
|
Pancreatic adenocarcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 23, 2013