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Biomarkers Study in Pancreatic Cancer

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666184
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01666184     History of Changes
Other Study ID Numbers: T3212
First Submitted: August 14, 2012
First Posted: August 16, 2012
Last Update Posted: August 16, 2012
Last Verified: August 2012

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