Chronic PancreatitisNCT00851955
Role of CXCR2 Ligands/CXCR2 Biological Axis in Pancreatic Cancer
An observational study of Chronic Pancreatitis and Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate their angiogenic phenotype. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Cancer
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2011
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Care
Who may be able to join
- Normal subjects - No documented clinical history of pancreatic diseases supported by at least 1 negative imaging test. (EUS, Ct scan or MRI)
- Chronic pancreatitis - Documented diagnosis of moderate to advanced chronic supported bpancreatitisy at least 1 positive imaging test. (EUS, Ct scan or MRI)
- Pancreatic Cancer - Documented tissue diagnosis (or clinical suspicion) of Pancreatic Cancer.
Who cannot join
- Exclusion criteria will include age younger than 18 yrs, pregnancy, previous pancreatic or gastric resection, and inability to tolerate routine endoscopy with conscious sedation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate their angiogenic phenotype. A corollary of this hypothesis is that the cell surface receptors (CXCR2) and the intracellular signaling pathways that mediate the angiogenic responses induced by ELR+ CXC-chemokines are potential targets for novel therapeutic interventions in PC.
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Medical subject headings
- Pancreatitis, Chronic, 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 |
|---|---|---|
| 1. Normal pancreas patients | Patients with no documented clinical history of pancreatic diseases supported by at least 1 negative imaging test (EUS, CT scan or MRI). | |
| 2. Chronic pancreatitis patients | Patients with documented diagnosis of moderate to advanced chronic pancreatitis supported by at least 1 positive imaging test (EUS,CT scan or MRI). | |
| 3. Pancreatic cancer patients | Patients with documented tissue diagnosis (or clinical suspicion) of Pancreatic Cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: One year
Secondary outcomes (1)
For pancreatic patients from whom tissue samples will be available, we will examine the association between presence/absence of each marker in the tissue versus the marker level in blood and in pancreatic juice.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Raimondo, M.D., Mayo Clinic
- Investigators
- Massimo Raimondo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851955
- Sponsor's protocol ID
- 07-000099
- Status last verified
- Jan 2016
- First submitted
- 25 Feb 2009
- Last updated
- 12 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CXCR2 Ligands/CXCR2 Biological Axis in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00851955
- Acronym / sponsor ID
- 07-000099
- Conditions
- Chronic Pancreatitis, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Feb 2009 (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.
The investigators hypothesize that the CXCR2 ligands/CXCR2 biological axis plays an important role in promoting angiogenesis in PC; and that the genetic changes and the microenvironment of the tumor regulate the expression of CXCR2 ligands/CXCR2 in PC in order to potentiate their angiogenic phenotype. A corollary of this hypothesis is that the cell surface receptors (CXCR2) and the intracellular signaling pathways that mediate the angiogenic responses induced by ELR+ CXC-chemokines are potential targets for novel therapeutic interventions in PC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Normal pancreas patients | – | –Patients with no documented clinical history of pancreatic diseases supported by at least 1 negative imaging test (EUS, CT scan or MRI). |
| 2. Chronic pancreatitis patients | – | –Patients with documented diagnosis of moderate to advanced chronic pancreatitis supported by at least 1 positive imaging test (EUS,CT scan or MRI). |
| 3. Pancreatic cancer patients | – | –Patients with documented tissue diagnosis (or clinical suspicion) of Pancreatic Cancer. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care
Key inclusion criteria (3 listed)
- Normal subjects - No documented clinical history of pancreatic diseases supported by at least 1 negative imaging test. (EUS, Ct scan or MRI)
- Chronic pancreatitis - Documented diagnosis of moderate to advanced chronic supported bpancreatitisy at least 1 positive imaging test. (EUS, Ct scan or MRI)
- Pancreatic Cancer - Documented tissue diagnosis (or clinical suspicion) of Pancreatic Cancer.
Key exclusion criteria (1 listed)
- Exclusion criteria will include age younger than 18 yrs, pregnancy, previous pancreatic or gastric resection, and inability to tolerate routine endoscopy with conscious sedation
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
All cause mortality
Time frame: One year
1 secondary outcome
For pancreatic patients from whom tissue samples will be available, we will examine the association between presence/absence of each marker in the tissue versus the marker level in blood and in pancreatic juice.
Time frame: One 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 12 Jan 2016.
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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.
Massimo Raimondo, MD principal investigator
Mayo Clinic
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 Chronic Pancreatitis and Pancreatic Cancer, run by Mayo Clinic 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 3 inclusion and 1 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 12 Jan 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?
All cause mortality (time frame: One 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 12 Jan 2016.