Pancreatic CancerNCT02277834
Characterizing the Pancreatic Cancer Proteome From Pancreatic Juice
An observational study of Pancreatic Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are collecting and studying the fluid produced by the pancreas as a way to detect pancreatic cancer at an earlier stage. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2016
- Phase
- Observational
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group A: Participants with a confirmed diagnosis of a pancreatic adenocarcinoma will be enrolled in this study. Potential participants will be identified from the Surgical Oncology and Gastroenterology outpatient settings. Group B: Participants with a confirmed diagnosis of chronic pancreatitis will be enrolled in this study. Participants will be derived from the Gastroenterology and Gastrointestinal Surgery outpatient setting. Group C: Participants undergoing endoscopy for non-pancreatic, non-neoplastic indications. The typical patient population we anticipate recruiting to this group with be those with non-malignant, non-pancreatitis biliary calculous disease. Participants will be derived from the Gastroenterology outpatient setting.
Who may be able to join
- Male or females that have suspected pancreatic adenocarcinoma, localized or metastatic.
- The pancreatic adenocarcinoma must be active, with active intra-pancreatic tumor documented within the last 3 months by CT or MRI scan.
- At least 19 years of age. (All Cohorts)
- In the Investigator's judgment, participant is mentally competent to provide informed consent to participate in the study. (All Cohorts)
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. (All Cohorts)
- Negative urine pregnancy test at screening, if applicable. (All Cohorts)
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- The patient must already have a completed, active consent for either endoscopic ultrasound(EUS) and/or endoscopic retrograde cholangiopancreatography (ERCP) at University of Alabama at Birmingham(UAB). (All Cohorts)
- Group B:
- Male or female patients that have had chronic pancreatitis for at least 6 months.
- CT abdomen or MRI abdomen within the last 3 months demonstrating no suspicion of pancreatic adenocarcinoma.
- Group C:
- 1.Male or female patients already scheduled to undergo upper endoscopy for non-pancreatic, non-neoplastic indications.
Who cannot join
- The participant is medically unfit to undergo upper endoscopy.
- No cancer-directed therapy administered within the last 3 months. This includes any of the following: surgical resection, chemotherapy, radiation therapy, immunologic or biologic therapy.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
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- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Participants who currently have a biliary stent in place.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- The endoscopic pancreatic biopsy does not show adenocarcinoma.
- Group B:
- The participant is medically unfit to undergo upper endoscopy.
- The participant has a suspicion of pancreatic adenocarcinoma on imaging within the last 3 months.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Participants who currently have a biliary stent in place.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Group C:
- The participant is medically unfit to undergo upper endoscopy.
- The participant has a history of, or current clinical suspicion of pancreatic adenocarcinoma or pancreatitis.
- The participant has a history of any type of gastrointestinal malignancy within the last 5 years.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
- Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
- Participants who currently have a biliary stent in place.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Characterizing the Pancreatic Adenocarcinoma Proteome From Pancreatic Juice
Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are collecting and studying the fluid produced by the pancreas as a way to detect pancreatic cancer at an earlier stage.
Read the detailed description
Pancreatic cancer is very difficult to detect and treat, and patients with this cancer generally live fewer years than patients with other types of cancer. Part of the reason why pancreatic cancer is so hard to treat is because it is usually discovered when it is too advanced to be able to treat. The goal of this protocol is to find a way to detect pancreatic cancer earlier, when it is still treatable in order to improve the survival of patients.
The pancreas is a gland which produces digestive juices that mix with food in the intestines. Normal patients as well as patients with pancreatic cancer produce these juices. Other researchers have collected this fluid from very small numbers of patients and their results suggest that pancreatic fluid can be used to detect pancreatic cancer. One of the major issues with these results is that pancreatic fluid from only a very few number of patients has been collected and analyzed. In order to find out whether the pancreatic fluid can be used as a standard test for pancreatic cancer, the fluid from a greater number of patients needs to be analyzed. Also, of all the different chemicals in the pancreatic fluid, in this study we will try to figure out what the most important chemicals are in diagnosing pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic adenocarcinoma | 15 patients receiving Endoscopic Retrograde Cholangiopancreatography with suspected pancreatic adenocarcinoma (localized or metastatic). | |
| chronic pancreatitis | 15 patients with a history of chronic pancreatitis that are having Endoscopic Retrograde Cholangiopancreatography . | |
| non-pancreatic, non-neoplastic disorders | 15 patients undergoing an Endoscopic Retrograde Cholangiopancreatography for non-pancreatic, non-neoplastic indications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proteomic signature of pancreatic adenocarcinoma , pancreatic cancer and control participants to the disease process
Characterization of the proteomic signature of patients with pancreatic adenocarcinoma, pancreatic cancer, and control participants. This will be accomplished by classifying a group or set of similar proteomic profiles(once we(once we have developed from the samples obtained a list of known proteomic profiles taht are found in all pancreatic adenocarcinoma subjects) that are specific to the disease process,of pancreatic adenocarcinoma.
Measured: 120 months from First subject enrolled
Secondary outcomes (1)
Compare the proteomic profile between pancreatic cancer and pancreatitis
Using the discovered pancreatic adenocarcinoma proteomic profile we will differentiate a documentable difference from pancreatic cancer and pancreatitis
Measured: 120 months from First subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo M Contreras, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277834
- Sponsor's protocol ID
- UAB 1361
- Status last verified
- May 2016
- First submitted
- 6 Oct 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Pancreatic Adenocarcinoma Proteome From Pancreatic Juice
- ClinicalTrials.gov ID
- NCT02277834
- Acronym / sponsor ID
- UAB 1361
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Oct 2014 (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.
Currently, X-rays and blood tests often miss pancreatic cancer. In this study, we are collecting and studying the fluid produced by the pancreas as a way to detect pancreatic cancer at an earlier stage.
Detailed description
Pancreatic cancer is very difficult to detect and treat, and patients with this cancer generally live fewer years than patients with other types of cancer. Part of the reason why pancreatic cancer is so hard to treat is because it is usually discovered when it is too advanced to be able to treat. The goal of this protocol is to find a way to detect pancreatic cancer earlier, when it is still treatable in order to improve the survival of patients.
The pancreas is a gland which produces digestive juices that mix with food in the intestines. Normal patients as well as patients with pancreatic cancer produce these juices. Other researchers have collected this fluid from very small numbers of patients and their results suggest that pancreatic fluid can be used to detect pancreatic cancer. One of the major issues with these results is that pancreatic fluid from only a very few number of patients has been collected and analyzed. In order to find out whether the pancreatic fluid can be used as a standard test for pancreatic cancer, the fluid from a greater number of patients needs to be analyzed. Also, of all the different chemicals in the pancreatic fluid, in this study we will try to figure out what the most important chemicals are in diagnosing pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pancreatic adenocarcinoma | – | –15 patients receiving Endoscopic Retrograde Cholangiopancreatography with suspected pancreatic adenocarcinoma (localized or metastatic). |
| chronic pancreatitis | – | –15 patients with a history of chronic pancreatitis that are having Endoscopic Retrograde Cholangiopancreatography . |
| non-pancreatic, non-neoplastic disorders | – | –15 patients undergoing an Endoscopic Retrograde Cholangiopancreatography for non-pancreatic, non-neoplastic indications. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group A: Participants with a confirmed diagnosis of a pancreatic adenocarcinoma will be enrolled in this study. Potential participants will be identified from the Surgical Oncology and Gastroenterology outpatient settings. Group B: Participants with a confirmed diagnosis of chronic pancreatitis will be enrolled in this study. Participants will be derived from the Gastroenterology and Gastrointestinal Surgery outpatient setting. Group C: Participants undergoing endoscopy for non-pancreatic, non-neoplastic indications. The typical patient population we anticipate recruiting to this group with be those with non-malignant, non-pancreatitis biliary calculous disease. Participants will be derived from the Gastroenterology outpatient setting.
Key inclusion criteria (12 listed)
- Male or females that have suspected pancreatic adenocarcinoma, localized or metastatic.
- The pancreatic adenocarcinoma must be active, with active intra-pancreatic tumor documented within the last 3 months by CT or MRI scan.
- At least 19 years of age. (All Cohorts)
- In the Investigator's judgment, participant is mentally competent to provide informed consent to participate in the study. (All Cohorts)
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. (All Cohorts)
Key exclusion criteria (32 listed)
- The participant is medically unfit to undergo upper endoscopy.
- No cancer-directed therapy administered within the last 3 months. This includes any of the following: surgical resection, chemotherapy, radiation therapy, immunologic or biologic therapy.
- Participants with a known allergy to secretin.
- Participants who are pregnant or lactating, or intending to become pregnant during the study.
- Participants of childbearing potential who refuse a pregnancy test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the proteomic signature of pancreatic adenocarcinoma , pancreatic cancer and control participants to the disease process
Time frame: 120 months from First subject enrolled
Characterization of the proteomic signature of patients with pancreatic adenocarcinoma, pancreatic cancer, and control participants. This will be accomplished by classifying a group or set of similar proteomic profiles(once we(once we have developed from the samples obtained a list of known proteomic profiles taht are found in all pancreatic adenocarcinoma subjects) that are specific to the disease process,of pancreatic adenocarcinoma.
1 secondary outcome
Compare the proteomic profile between pancreatic cancer and pancreatitis
Time frame: 120 months from First subject enrolled
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 13 May 2016.
- Individual participant dataSharing planned: No
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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.
Carlo M Contreras, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by University of Alabama at Birmingham at 1 site in United States.
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 12 inclusion and 32 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Compare the proteomic signature of pancreatic adenocarcinoma , pancreatic cancer and control participants to the disease process (time frame: 120 months from First subject enrolled). 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 13 May 2016.