Clinical trial NCT01666184: Biomarkers Study in Pancreatic Cancer
Official title: Biomarkers Study in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biomarkers Study in Pancreatic Cancer
Keywords: Biomarkers study
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Chang Gung Memorial Hospital
name: Taipei Veterans General Hospital, Taiwan
name: Mackay Memorial Hospital
name: Taichung Veterans General Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Veterans General Hospital.
name: Kaohsiung Medical University
First posted: 2012-08-16
Enrollment: 270
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for pancreatic cancer.
3. Patients have to sign informed consent for tissue specimen collection, according to the regulation of DOH.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yi-Ming Shyr, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Tsann-Long Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mackay Memorial Hospital Taipei, Taiwan
name: Ruey-Kuen Hsieh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.