Pancreatic AdenocarcinomaNCT01753479
Spectroscopy From Duodenum
A study testing Spectroscopy device in people with Pancreatic Adenocarcinoma, run by Olympus Corporation at 4 sites in 3 countries.
Trial summary
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Spectroscopy device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2013to 30 Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common inclusion criterion
- Age is 18 years or older.
- Informed consent was obtained.
- 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.
Who cannot join
- Common exclusion criterion
- Severe cardiac disease
- Severe respiratory disease
- Bleeding disorders
- Pregnancy
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224
About this study
Official title: Duodenal Spectroscopy Study for Cancer Diagnosis
Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.
Read the 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.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Spectroscopy device
- Keywords
- Pancreatic adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectroscopy deviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test subject | Experimental | Not described Receives: Other: Spectroscopy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center, Catholic University of the Sacred Heart, Erasme University Hospital
- Responsible party
- Sponsor
- Investigators
- Michael B Wallace, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753479
- Sponsor's protocol ID
- OMSC-Mag-1
- Status last verified
- Mar 2017
- First submitted
- 17 Dec 2012
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duodenal Spectroscopy Study for Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT01753479
- Acronym / sponsor ID
- OMSC-Mag-1
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Olympus CorporationIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center, Catholic University of the Sacred Heart, Erasme University Hospital
- Study start
- Jan 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 20 Dec 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test subject | Experimental | Other: Spectroscopy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Common inclusion criterion
- Inclusion criterion for PC suspicious cohort * A EUS or ERCP is scheduled to suspected pancreatic disorder.
Key exclusion criteria (5 listed)
- Common exclusion criterion
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 |
|---|---|---|
| Spectroscopy deviceSpectrum 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. | Other | Test subject |
Primary outcome
The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort
Time frame: 1 year
To clarify that there is the statistically-significant difference between two cohorts.
1 secondary outcome
The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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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.
Michael B Wallace, M.D. principal investigator
Mayo Clinic
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectroscopy device in people with Pancreatic Adenocarcinoma, run by Olympus Corporation at 4 sites in 3 countries.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort (time frame: 1 year). 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 Mar 2017.