Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biomarkers Study in Pancreatic Cancer

This study is enrolling participants by invitation only.
Sponsor:
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
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01666184
First received: August 14, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Biospecimen Retention:   Samples With DNA

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)
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666184

Sponsors and Collaborators
National Health Research Institutes, Taiwan
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
Investigators
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 Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014