Clinical trial NCT01753479: Spectroscopy From Duodenum
Official title: Duodenal Spectroscopy Study for Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic adenocarcinoma
Lead sponsor: Olympus Corporation
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Catholic University of the Sacred Heart
name: Erasme University Hospital
First posted: 2012-12-20
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort
timeFrame: 1 year
Secondary outcomes:
measure: The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
state: Brussels-Capital Region
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore
state: Lazio
Study officials:
affiliation: Mayo Clinic
name: Michael B Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References: