Pancreatic CancerNCT01127815
Identify the Clinical Significance and Potential Implications of Peritoneal Washing Cytology (PWC) in Patients With Pancreatic Cancer
An observational study of Pancreatic Cancer, run by National Taiwan University Hospital.
Trial summary
Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are largely due to a high incidence of local or peritoneal recurrence even after curative R0 resection. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Dec 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: operated in Surgical Department of National Taiwan University Hospital
Who may be able to join
- Patients with pancreatic cancers, other non-ductal pancreatic cancers , and benign pancreatic tumors (as negative control population) operated in Surgical Department after IRB proof and receiving patients' informed consent.
Who cannot join
- Pregnant women
About this study
Official title: Identify the Clinical Significance and Potential Implications of PWC in Patients With Pancreatic Cancer
Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are largely due to a high incidence of local or peritoneal recurrence even after curative R0 resection. If occult microscopic metastasis or residual cancer could be predicted correctly and identify the high risk of peritoneal recurrence, we may have chance to treat these patients by different multimodal locoregional or adjuvant therapy to improve the treatment outcome.
Read the detailed description
The purpose of this study has three specific aims: (1) to determine the relationship between peritoneal washing cytology (PWC) results and clinicopathologic parameters of pancreatic cancers, (2) to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, (3) to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.
- Conditions
- Pancreatic Cancer
- Keywords
- Peritoneal washing cytology, pancreatic cancer, peritoneal metastasis, anoikis, to determine the relationship between PWC results and clinicopathologic parameters of pancreatic cancers, to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.
- Medical subject headings
- Pancreatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
- Study completionDec 2011 (estimated)
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 National Taiwan University HospitalThe 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
- Case-control
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ching-Yao Yang, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127815
- Sponsor's protocol ID
- 201004002R
- Status last verified
- May 2010
- First submitted
- 20 May 2010
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify the Clinical Significance and Potential Implications of PWC in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01127815
- Acronym / sponsor ID
- 201004002R
- Conditions
- Pancreatic Cancer
- Keywords
- Peritoneal washing cytology, pancreatic cancer, peritoneal metastasis, anoikis, to determine the relationship between PWC results and clinicopathologic parameters of pancreatic cancers, to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 21 May 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.
Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are largely due to a high incidence of local or peritoneal recurrence even after curative R0 resection. If occult microscopic metastasis or residual cancer could be predicted correctly and identify the high risk of peritoneal recurrence, we may have chance to treat these patients by different multimodal locoregional or adjuvant therapy to improve the treatment outcome.
Detailed description
The purpose of this study has three specific aims: (1) to determine the relationship between peritoneal washing cytology (PWC) results and clinicopathologic parameters of pancreatic cancers, (2) to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, (3) to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- operated in Surgical Department of National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Patients with pancreatic cancers, other non-ductal pancreatic cancers , and benign pancreatic tumors (as negative control population) operated in Surgical Department after IRB proof and receiving patients' informed consent.
Key exclusion criteria (1 listed)
- Pregnant women
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2010.
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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.
Ching-Yao Yang, M.D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by National Taiwan University Hospital.
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: status not confirmed, as of the sponsor's last update on 21 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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 21 May 2010.