Pancreatic CancerNCT03001505
Registry for Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Duke University at 2 sites in United States.
Trial summary
This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2017to Apr 2037
- How long will I take part?
- 10 Years
- 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 diagnosed with pancreatic cancer who are treated at DUHS
Who may be able to join
- Pancreatic cancer
Who cannot join
- Younger than 18 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Health System
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Registry to Evaluate Multi-modality Therapies for Pancreatic Cancer
This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreatic cancer | Patients diagnosed with pancreatic cancer evaluated at this institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival from Diagnosis to time of death
Measured: 10 years
Secondary outcomes (3)
Disease-free survival
length of time with no evidence of disease
Measured: 10 years
Metastasis
Radiographic or surgical evidence of disease spread beyond the pancreas (or resection bed if post surgery).
Measured: 10 years
Local recurrence
Radiographic evidence of disease recurrence in the resection bed, if post surgery.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start4 May 2017
- Primary completionApr 2037 (estimated)
- Study completionApr 2037 (estimated)
Why it stopped: Study design changed to clinical database only with no research question to be studied.
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 Duke 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
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabino Zani, MD, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001505
- Sponsor's protocol ID
- Pro00075769
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Evaluate Multi-modality Therapies for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03001505
- Acronym / sponsor ID
- Pro00075769
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study design changed to clinical database only with no research question to be studied.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- Apr 2037 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 23 Dec 2016 (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 is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic cancer | – | –Patients diagnosed with pancreatic cancer evaluated at this institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pancreatic cancer who are treated at DUHS
Key inclusion criteria (1 listed)
- Pancreatic cancer
Key exclusion criteria (1 listed)
- Younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 10 years
Survival from Diagnosis to time of death
3 secondary outcomes
Disease-free survival
Time frame: 10 years
Metastasis
Time frame: 10 years
Local recurrence
Time frame: 10 years
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 6 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Sabino Zani, MD principal investigator
DUHS
2 sites 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 Duke University at 2 sites 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 1 inclusion and 1 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Overall survival (time frame: 10 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 6 Dec 2017.