Pancreatic CancerNCT00767234
Permission to Collect Blood Over Time for Research
An observational study of Pancreatic Cancer and Gastrointestinal Neoplasms, run by Stanford University at 1 site in United States.
Trial summary
To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Gastrointestinal Neoplasms, Colon Rectal Cancer Adenocarcinoma
- What is being tested?
- Observation
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active cancers of the GI tract
Who may be able to join
- Male or female, >= 18 years old. There are no ethnic restrictions.
- Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease
- Ability to understand and the willingness to sign a written informed consent document.
- Existing staging CT imaging study
Who cannot join
- Life expectancy < 6 months
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Known pregnancy or positive urine pregnancy test in pre-menopausal women
- On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors)
- No CT imaging studies, or contraindications to undergoing CT imaging
- Existing or anticipated need for a tunneled central venous catheter
- Clinic visitation to Stanford Cancer center for secondary consultation purposes only
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers
To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.
- Conditions
- Pancreatic Cancer, Gastrointestinal Neoplasms, Colon Rectal Cancer Adenocarcinoma, Esophageal Cancer, Gall Bladder Cancer, Gastric (Stomach) Cancer
- Being tested
- Observation
- Medical subject headings
- Pancreatic Neoplasms, Gastrointestinal Neoplasms, Esophageal Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Gastrointestinal Stromal Tumors, Carcinoma, Hepatocellular, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationProcedure or surgery
Standard of Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Biomarkers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Accrual issues - Low Accrual
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 Stanford UniversityThe 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haruka Itakura, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767234
- Sponsor's protocol ID
- GI0003
- Other IDs
- GI0003, 8502
- Status last verified
- Jul 2016
- First submitted
- 3 Oct 2008
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers
- ClinicalTrials.gov ID
- NCT00767234
- Acronym / sponsor ID
- GI0003
- Conditions
- Pancreatic Cancer, Gastrointestinal Neoplasms, Colon Rectal Cancer Adenocarcinoma, Esophageal Cancer, Gall Bladder Cancer, Gastric (Stomach) Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Accrual issues - Low Accrual
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Oct 2008 (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.
To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active cancers of the GI tract
Key inclusion criteria (4 listed)
- Male or female, >= 18 years old. There are no ethnic restrictions.
- Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease
- Ability to understand and the willingness to sign a written informed consent document.
- Existing staging CT imaging study
Key exclusion criteria (8 listed)
- Life expectancy < 6 months
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Known pregnancy or positive urine pregnancy test in pre-menopausal women
- On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors)
- No CT imaging studies, or contraindications to undergoing CT imaging
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 |
|---|---|---|
| ObservationStandard of Care | Procedure or surgery | – |
Primary outcome
Identify Biomarkers
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Accrual issues - Low Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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.
Haruka Itakura principal investigator
Stanford University
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 and Gastrointestinal Neoplasms, run by Stanford University 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 8 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: stopped early, as of the sponsor's last update on 11 Jul 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 was stopped early (reason given: Accrual issues - Low Accrual). Results are not available in the source record.
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?
Identify Biomarkers (time frame: 3 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 11 Jul 2016.