Pancreatic CancerNCT00900016
Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery
An observational study of Pancreatic Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- protein expression analysis, western blotting and immunohistochemistry staining method
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 23 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgury patients scheduled to undergo a resection or exploration of their pancreatic tumor
DISEASE CHARACTERISTICS:
- Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer
- Localized disease
- Scheduled to undergo a resection or exploration of their pancreatic tumor
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.
Read the detailed description
OBJECTIVES:
Primary
- To assess the degree of fibroblast activation protein (FAP) enzymatic activity at the tumor site in patients with localized pancreatic cancer.
Secondary
- To explore correlations between tumor stromal FAP enzymatic activity and stromal α_2-antiplasmin levels.
- To explore correlations between tumor FAP enzymatic activity and plasma dipeptidyl peptidase and plasma α_2-antiplasmin converting enzyme activity as potential surrogates.
OUTLINE: Patients undergo fine-needle aspiration of tumor or suspected mass at baseline. Tumor samples are analyzed by IHC for fibroblast activation protein (FAP) expression, immunocapture assay for ex vivo FAP enzymatic activity, and western analysis for FAP concentrations. Blood samples are collected weekly and analyzed for dipeptidyl peptidase activity by ELISA and α_2-antiplasmin converting enzyme.
- Conditions
- Pancreatic Cancer
- Being tested
- protein expression analysis, western blotting, immunohistochemistry staining method, immunologic technique, laboratory biomarker analysis
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II 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.
protein expression analysisGenetic
western blottingGenetic
immunologic techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression
Measured: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Secondary outcomes (2)
Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAP
Measured: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Potential plasma surrogates of plasma dipeptidyl peptidase activity and plasma antiplasmin converting enzyme
Measured: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2007
- Primary completionDec 2013
- Study completion23 Jun 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 Fox Chase Cancer CenterThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven Cohen, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900016
- Sponsor's protocol ID
- CDR0000579635
- Other IDs
- 07-011
- Status last verified
- Sep 2017
- First submitted
- 9 May 2009
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Study of Fibroblast Activity Protein in Patients With Localized Pancreas Cancer Undergoing Surgical Resection
- ClinicalTrials.gov ID
- NCT00900016
- Acronym / sponsor ID
- CDR0000579635
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 12 May 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.
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.
Detailed description
OBJECTIVES:
Primary
- To assess the degree of fibroblast activation protein (FAP) enzymatic activity at the tumor site in patients with localized pancreatic cancer.
Secondary
- To explore correlations between tumor stromal FAP enzymatic activity and stromal α_2-antiplasmin levels.
- To explore correlations between tumor FAP enzymatic activity and plasma dipeptidyl peptidase and plasma α_2-antiplasmin converting enzyme activity as potential surrogates.
OUTLINE: Patients undergo fine-needle aspiration of tumor or suspected mass at baseline. Tumor samples are analyzed by IHC for fibroblast activation protein (FAP) expression, immunocapture assay for ex vivo FAP enzymatic activity, and western analysis for FAP concentrations. Blood samples are collected weekly and analyzed for dipeptidyl peptidase activity by ELISA and α_2-antiplasmin converting enzyme.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgury patients scheduled to undergo a resection or exploration of their pancreatic tumor
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 |
|---|---|---|
| protein expression analysis | Genetic | – |
| western blotting | Genetic | – |
| immunohistochemistry staining method | Other | – |
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression
Time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
2 secondary outcomes
Feasibility of exploiting the circulatory compartment to identify surrogates of tumor FAP
Time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
Potential plasma surrogates of plasma dipeptidyl peptidase activity and plasma antiplasmin converting enzyme
Time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence
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 11 Sep 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.
Steven Cohen, MD principal investigator
Fox Chase Cancer Center
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 Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 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?
Independence of tumor fibroblast activation protein (FAP) activity and Met-α2-antiplasmin expression (time frame: Within 28 days for prior to surgery and at 3 month intervals for up to 2 years or recurrence). 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 11 Sep 2017.