Pancreatic CancerSPORE-PANCNCT01392027
Biospecimens for Identification of Diseases of the Pancreas.
A study testing Blood Draw in people with Pancreatic Cancer and Chronic Pancreatitis, run by University of Michigan at 1 site in United States.
Trial summary
This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Chronic Pancreatitis, Type II Diabetes
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 712 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 31 Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overall Inclusion (all subjects must meet these criteria to be enrolled)
- Adults 18 years of age or older
- Able to physically tolerate removal of 50 ml of blood
- Willing to sign informed consent.
Who cannot join
- Pregnant or lactating
- Known HIV/AIDS or Hepatitis C
- Prepped for colonoscopy at the time of blood collection
- Unable to understand English
- Receiving chemotherapy or radiation at time of enrollment
- Any cancer within 5 years of enrollment except any of the following:
Show all 9Show fewer
- Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin
- Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation)
- Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.
This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls.
We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.
Read the detailed description
The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI and several COREs, including a biospecimen core. Each project that has a human subjects component will require a separate protocol and IRB submission when those projects are to begin.
The specific populations we are recruiting are determined by the aims of project 2 and by the need to create a repository as part of the biospecimen core (please see the grant for details on the aims of these 2 projects).
A specially designed database is being built for this study to handle the data aspects. Our collaborators at Dartmouth College have significant experience in managing data as they have been our partners for our work in the EDRN (PI Brenner). Case report forms and other data collection tools have been developed and are being used to populate the database. All of the actual data will be completely deidentified per HIPAA regulations.
We intend to model the data and specimen collection on the model used by our work with the NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded aliquots, and standardized data collection forms (CRFs).
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis, Type II Diabetes, Pancreatic Cysts, Healthy Control
- Being tested
- Blood Draw
- Keywords
- Pancreatic Cancer, Chronic Pancreatitis, Diseases of the pancreas
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic, Diabetes Mellitus, Type 2, Pancreatic Cyst, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Blood draw for research specimens only
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of glycoprotein panel as a pancreatic cancer biomarker
To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startApr 2011
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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 MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Missy Tuck, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392027
- Sponsor's protocol ID
- P50-CA13081001A2
- Acronym
- SPORE-PANC
- Status last verified
- Nov 2017
- First submitted
- 6 Jul 2011
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.
- ClinicalTrials.gov ID
- NCT01392027
- Acronym / sponsor ID
- SPORE-PANC / P50-CA13081001A2
- Conditions
- Pancreatic Cancer, Chronic Pancreatitis, Type II Diabetes, Pancreatic Cysts, Healthy Control
- Keywords
- Pancreatic Cancer, Chronic Pancreatitis, Diseases of the pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 12 Jul 2011 (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.
This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls.
We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.
Detailed description
The recently funded GI SPORE, here at the University of Michigan, is focused on pancreatic and colon diseases. This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. A SPORE is an NCI-funded, Specialized Program in Research Excellence, with specific requirements. Those requirements include 4 projects with a clinical and a basic science Co-PI and several COREs, including a biospecimen core. Each project that has a human subjects component will require a separate protocol and IRB submission when those projects are to begin.
The specific populations we are recruiting are determined by the aims of project 2 and by the need to create a repository as part of the biospecimen core (please see the grant for details on the aims of these 2 projects).
A specially designed database is being built for this study to handle the data aspects. Our collaborators at Dartmouth College have significant experience in managing data as they have been our partners for our work in the EDRN (PI Brenner). Case report forms and other data collection tools have been developed and are being used to populate the database. All of the actual data will be completely deidentified per HIPAA regulations.
We intend to model the data and specimen collection on the model used by our work with the NCI-EDRN. This includes a customized database, the use of kits with pre-labled, bar-coded aliquots, and standardized data collection forms (CRFs).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overall Inclusion (all subjects must meet these criteria to be enrolled)
- Adults 18 years of age or older
- Able to physically tolerate removal of 50 ml of blood
- Willing to sign informed consent.
Key exclusion criteria (9 listed)
- Pregnant or lactating
- Known HIV/AIDS or Hepatitis C
- Prepped for colonoscopy at the time of blood collection
- Unable to understand English
- Receiving chemotherapy or radiation at time of enrollment
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 |
|---|---|---|
| Blood DrawBlood draw for research specimens only | Procedure or surgery | – |
Primary outcome
Validation of glycoprotein panel as a pancreatic cancer biomarker
Time frame: 5 years
To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer.
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 8 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Draw in people with Pancreatic Cancer and Chronic Pancreatitis, run by University of Michigan 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 4 inclusion and 9 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 8 Nov 2017. 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?
Validation of glycoprotein panel as a pancreatic cancer biomarker (time frame: 5 years). 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 8 Nov 2017.