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Duodenal Spectroscopy Study for Cancer Diagnosis


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Adenocarcinoma

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Trial Information

Duodenal Spectroscopy Study for Cancer Diagnosis


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort

Outcome Description:

To clarify that there is the statistically-significant difference between two cohorts.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Michael B Wallace, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Borad

Study ID:

OMSC-Mag-1

NCT ID:

NCT01753479

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Pancreatic adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location
The University of Texas M. D. Anderson Cancer Center Houston, Texas  77030
Mayo Clinic Florida Jacksonville, Florida  32224