Pancreas CancerPhase 1NCT01092689
The Role of Meat-borne Carcinogens in Pancreatic Cancer
A Phase 1 study testing PhiP in people with Pancreas Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- PhiP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2012
- Phase
- Phase 1
- 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
- At least 18 years old.
- Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.
- Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after PhIP administration.
- Voluntary written informed consent (PhIP consent and Caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Who cannot join
- CA-19-9 equal to or above 400.
- Tumor size >3.5 cm.
- Fluid in the abdomen (ascites).
- Conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement.
- Pregnant or lactating (for women).
- Uncontrolled cardiovascular disease; e.g. hypertension, angina, etc.
- Patients who are intolerant of a 200 mg dose of caffeine or who otherwise do not wish to participate in the caffeine assay when consent is sought for the primary consent will be considered refusers and will not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Understanding the Role of Meat-Borne Carcinogen in Pancreatic Cancer Etiology
We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas.
Read the detailed description
Pancreatic cancer is rapidly fatal in most cases and little is known about its causes. Identifying and modifying risk factors can reduce mortality through prevention. Carcinogens that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas. We hypothesize that the meat-derived carcinogen will bind to DNA in the pancreas. The amount of PhIP ingested is equivalent to the amount in two very well-done barbecued chicken breasts and the dose of radioactivity is comparable to a typical chest x-ray. This research can increase understanding of pancreatic carcinogenesis, facilitating the design of prevention strategies.
- Conditions
- Pancreas Cancer
- Being tested
- PhiP
- Keywords
- heterocyclic amines, PhIP, Meat, pancreas neoplasms
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhiPDrug
1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP
| Study group | Role | What they receive |
|---|---|---|
| PhIP | Experimental | Prior to surgery, consented subjects will ingest a capsule containing [14C]PhIP. This amount of [14C]PhIP (84 micrograms PhIP; 15.6 micro-curies) is equivalent to that in 2 very well done grilled/barbecued chicken breasts (Sinha 1995); the amount of radioactivity is equivalent to the dose received in a commercial airline flying at 30,000 ft. for 5 h (HPS 2007) or to the amount received during a typical chest x-ray. Receives: Drug: PhiP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify and characterize HCA-DNA adducts in resected human pancreatic tissue after a dietary relevant dose of PhIP, the most mass abundant HCA in charred meat.
Measured: 6 hours post ingestion
Secondary outcomes (1)
Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.
Measured: From 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Needed New IND per FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, Lawrence Livermore National Laboratory
- Responsible party
- Sponsor
- Investigators
- Kristin E Anderson, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092689
- Sponsor's protocol ID
- 2007NT128
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2010
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Meat-Borne Carcinogen in Pancreatic Cancer Etiology
- ClinicalTrials.gov ID
- NCT01092689
- Acronym / sponsor ID
- 2007NT128
- Conditions
- Pancreas Cancer
- Keywords
- heterocyclic amines, PhIP, Meat, pancreas neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Needed New IND per FDA
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Arkansas, Lawrence Livermore National Laboratory
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Mar 2010 (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.
We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas.
Detailed description
Pancreatic cancer is rapidly fatal in most cases and little is known about its causes. Identifying and modifying risk factors can reduce mortality through prevention. Carcinogens that form in meat cooked at high temperatures may be modifiable risk factors for pancreatic cancer, but direct evidence is needed to demonstrate involvement in pancreas tissue. We propose to recruit subjects scheduled for pancreatectomy as a treatment for pancreatic cancer. These subjects will ingest a very low dose of radiolabeled PhIP, a meat-derived carcinogen, and a small amount of resected tissue (waste) will be analyzed with highly sensitive technology to determine if this carcinogen binds to DNA in the pancreas. We hypothesize that the meat-derived carcinogen will bind to DNA in the pancreas. The amount of PhIP ingested is equivalent to the amount in two very well-done barbecued chicken breasts and the dose of radioactivity is comparable to a typical chest x-ray. This research can increase understanding of pancreatic carcinogenesis, facilitating the design of prevention strategies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PhIP | Experimental | Drug: PhiPPrior to surgery, consented subjects will ingest a capsule containing [14C]PhIP. This amount of [14C]PhIP (84 micrograms PhIP; 15.6 micro-curies) is equivalent to that in 2 very well done grilled/barbecued chicken breasts (Sinha 1995); the amount of radioactivity is equivalent to the dose received in a commercial airline flying at 30,000 ft. for 5 h (HPS 2007) or to the amount received during a typical chest x-ray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old.
- Adequate hepatic function within 4 weeks of study enrollment defined as bilirubin ≤ 2 mg/dl and ALT, AST, and alkaline phosphatase ≤ 2 times the upper limit of normal.
- Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (i.e., a hormonal contraceptive. intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 4 months after PhIP administration.
- Voluntary written informed consent (PhIP consent and Caffeine assay consent) before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Key exclusion criteria (7 listed)
- CA-19-9 equal to or above 400.
- Tumor size >3.5 cm.
- Fluid in the abdomen (ascites).
- Conditions present, which, in the opinion of the surgeon, could make resection difficult, e.g., extensive vascular involvement.
- Pregnant or lactating (for women).
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 |
|---|---|---|
| PhiP1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP | Drug | PhIP |
Primary outcome
Quantify and characterize HCA-DNA adducts in resected human pancreatic tissue after a dietary relevant dose of PhIP, the most mass abundant HCA in charred meat.
Time frame: 6 hours post ingestion
1 secondary outcome
Quantify [14C]PhIP and [14C]PhIP metabolites in urine and plasma.
Time frame: From 0 to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
Kristin E Anderson, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PhiP in people with Pancreas Cancer, run by University of Minnesota 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 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: withdrawn, as of the sponsor's last update on 26 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quantify and characterize HCA-DNA adducts in resected human pancreatic tissue after a dietary relevant dose of PhIP, the most mass abundant HCA in charred meat. (time frame: 6 hours post ingestion). 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 26 Jun 2020.