Biomarkers Study in Pancreatic CancerNCT01666184
Biomarkers Study in Pancreatic Cancer
An observational study of Biomarkers Study in Pancreatic Cancer, run by National Health Research Institutes, Taiwan.
Trial summary
Study Design: Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent. The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Biomarkers Study in Pancreatic Cancer
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We expect to collect tissue samples from 270 pancreatic cancer patients of resectable pancreatic cancer. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.
Who may be able to join
- Patients enrolled to TCOG 3207 study: A Randomized Phase III Study of Adjuvant Gemcitabine versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection.
- Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for pancreatic cancer.
- Patients have to sign informed consent for tissue specimen collection, according to the regulation of DOH.
Who cannot join
None listed.
About this study
Study Design:
Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent.
The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.
Read the detailed description
We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.
- Conditions
- Biomarkers Study in Pancreatic Cancer
- Keywords
- Biomarkers study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biomarkers Study in Pancreatic CancerStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Veterans General Hospital., Kaohsiung Medical University
- Responsible party
- Sponsor
- Investigators
- Yi-Ming Shyr, M.D., Principal investigator, Taipei Veterans General Hospital, TaiwanTsann-Long Hwang, M.D., Principal investigator, Chang Gung Memorial HospitalRuey-Kuen Hsieh, M.D., Principal investigator, Mackay Memorial Hospital Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666184
- Sponsor's protocol ID
- T3212
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsai YC, Chen SL, Peng SL, Tsai YL, Chang ZM, Chang VH, Ch'ang HJ. Upregulating sirtuin 6 ameliorates glycolysis, EMT and distant metastasis of pancreatic adenocarcinoma with kruppel-like factor 10 deficiency. Exp Mol Med. 2021 Oct;53(10):1623-1635. doi: 10.1038/s12276-021-00687-8. Epub 2021 Oct 26.
PubMed 34702956
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Study in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01666184
- Acronym / sponsor ID
- T3212
- Conditions
- Biomarkers Study in Pancreatic Cancer
- Keywords
- Biomarkers study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Kaohsiung Veterans General Hospital., Kaohsiung Medical University
- Study start
- Sep 2012
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Aug 2012 (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.
Study Design:
Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent.
The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.
Detailed description
We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We expect to collect tissue samples from 270 pancreatic cancer patients of resectable pancreatic cancer. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.
Key inclusion criteria (3 listed)
- Patients enrolled to TCOG 3207 study: A Randomized Phase III Study of Adjuvant Gemcitabine versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection.
- Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for pancreatic cancer.
- Patients have to sign informed consent for tissue specimen collection, according to the regulation of DOH.
Key exclusion criteria (0 listed)
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 16 Aug 2012.
- Derived from this study: PubMed 34702956Tsai YC, Chen SL, Peng SL, Tsai YL, Chang ZM, Chang VH, Ch'ang HJ. Upregulating sirtuin 6 ameliorates glycolysis, EMT and distant metastasis of pancreatic adenocarcinoma with kruppel-like factor 10 deficiency. Exp Mol Med. 2021 Oct;53(10):1623-1635. doi: 10.1038/s12276-021-00687-8. Epub 2021 Oct 26.
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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.
Yi-Ming Shyr, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
Tsann-Long Hwang, M.D. principal investigator
Chang Gung Memorial Hospital
Ruey-Kuen Hsieh, M.D. principal investigator
Mackay Memorial Hospital Taipei, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers Study in Pancreatic Cancer, run by National Health Research Institutes, Taiwan.
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 3 inclusion and 0 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 16 Aug 2012. 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?
On the ClinicalTrials.gov record for NCT01666184, which also lists 1 linked publication.
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 16 Aug 2012.