PancreatitisAPPRENTICE2NCT03075631
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
An observational study of Pancreatitis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study is an ancillary of APPRENTICE. This will be the international based study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Questionnaire
- How many people
- 1,183 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 4 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Acute Pancreatitis
Who may be able to join
- The diagnosis of AP based upon presence of two out of the three following criteria:
- Abdominal pain typical to AP
- Serum amylase or lipase levels more than three times the upper limit of normal
- Imaging findings suggestive of AP
- Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).
Who cannot join
- Age under 18 years
- Unwilling to provide consent by patient or his/her proxy
- Presence of pancreatic cancer
- Presence of chronic pancreatitis
- Occurrence of AP following a multiple trauma episode
- Having history of organ transplant
- Presence of any cancer which required chemotherapy or radiation therapy in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
This study is an ancillary of APPRENTICE. This will be the international based study.
Read the detailed description
This study is an ancillary of APPRENTICE. This will be the international based study. The initial study design with discussions about the different variables to be included into our prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. We now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited.University of Pittsburgh will be responsible for collecting all required regulatory documents from other sites. Developing templates for questionnaires and other data collection forms. Will train approved sites on procedures. The coordinating center will be the recipient of de-identified data and will not be involved in the collection of data.
Note that copies of training records, licenses, certificates should be maintained in the study regulatory binder and are subject to audit by the Research Conduct and Compliance Office (RCCO).
- Conditions
- Pancreatitis
- Being tested
- Questionnaire
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Pancreatitis | Patients with Acute Pancreatitis Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with pancreatic necrosis as assessed by their clinical course.
Evaluation of the existing risks, predictive scores, and markers of severe disease.
Measured: 12 months
Number of patients with persistent organ failure as assessed by their clinical course.
Evaluation of the current management and outcomes of acute pancreatitis around the world.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startDec 2015
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 1,183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Papachristou, University of Pittsburgh
- Investigators
- Georgios I Papachristou, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075631
- Sponsor's protocol ID
- PRO15100089
- Acronym
- APPRENTICE2
- Status last verified
- May 2020
- First submitted
- 2 Feb 2017
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: The results will be shared with the other IRB approved sites associated with this study.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
- ClinicalTrials.gov ID
- NCT03075631
- Acronym / sponsor ID
- APPRENTICE2 / PRO15100089
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,183 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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.
This study is an ancillary of APPRENTICE. This will be the international based study.
Detailed description
This study is an ancillary of APPRENTICE. This will be the international based study. The initial study design with discussions about the different variables to be included into our prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. We now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited.University of Pittsburgh will be responsible for collecting all required regulatory documents from other sites. Developing templates for questionnaires and other data collection forms. Will train approved sites on procedures. The coordinating center will be the recipient of de-identified data and will not be involved in the collection of data.
Note that copies of training records, licenses, certificates should be maintained in the study regulatory binder and are subject to audit by the Research Conduct and Compliance Office (RCCO).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Pancreatitis | – | Other: QuestionnairePatients with Acute Pancreatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Acute Pancreatitis
Key inclusion criteria (5 listed)
- The diagnosis of AP based upon presence of two out of the three following criteria:
- Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).
Key exclusion criteria (7 listed)
- Age under 18 years
- Unwilling to provide consent by patient or his/her proxy
- Presence of pancreatic cancer
- Presence of chronic pancreatitis
- Occurrence of AP following a multiple trauma episode
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 |
|---|---|---|
| QuestionnaireQuestionnaires | Other | Patients with Acute Pancreatitis |
Primary outcome
Number of patients with pancreatic necrosis as assessed by their clinical course.
Time frame: 12 months
Evaluation of the existing risks, predictive scores, and markers of severe disease.
Number of patients with persistent organ failure as assessed by their clinical course.
Time frame: 12 months
Evaluation of the current management and outcomes of acute pancreatitis around the world.
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 6 May 2020.
- Individual participant dataSharing planned: Undecided. The results will be shared with the other IRB approved sites associated with this study.
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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.
Georgios I Papachristou, MD principal investigator
University of Pittsburgh
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 Pancreatitis, run by University of Pittsburgh 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 5 inclusion and 7 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 6 May 2020. 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?
Number of patients with pancreatic necrosis as assessed by their clinical course. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 6 May 2020.