Biomarkers Study in Pancreatic Cancer
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Purpose
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.
| Condition |
|---|
|
Biomarkers Study in Pancreatic Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Biomarkers Study in Pancreatic Cancer |
The specimen and clinical information will be collected and delivered to the laboratory of Dr. Hui-Ju Ch'ang over NICR, NHRI, Tainan .
| Estimated Enrollment: | 270 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- 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.
Contacts and Locations| Principal Investigator: | Yi-Ming Shyr, M.D. | Taipei Veterans General Hospital,Taiwan |
| Principal Investigator: | Tsann-Long Hwang, M.D. | Chang Gung Memorial Hospital |
| Principal Investigator: | Ruey-Kuen Hsieh, M.D. | Mackay Memorial Hospital Taipei, Taiwan |
More Information
No publications provided
| Responsible Party: | National Health Research Institutes, Taiwan |
| ClinicalTrials.gov Identifier: | NCT01666184 History of Changes |
| Other Study ID Numbers: | T3212 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | Department of Health : Taiwan |
Keywords provided by National Health Research Institutes, Taiwan:
|
Biomarkers study |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013