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NCT01666184 Clinical Trial

Biomarkers Study in Pancreatic Cancer

Biomarkers Study in Pancreatic Cancer Clinical Trial

Official title:
Biomarkers Study in Pancreatic Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01666184
Other study ID # T3212
Secondary ID
Status Enrolling by invitation
Phase N/A
First received August 14, 2012
Last updated August 14, 2012
Start date September 2012
Est. completion date December 2017

Study information
Verified date August 2012
Source National Health Research Institutes, Taiwan
Contact n/a
Is FDA regulated No
Health authority Department of Health : Taiwan
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 270
Est. completion date December 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (9)
Lead Sponsor Collaborator
National Health Research Institutes, Taiwan Chang Gung Memorial Hospital, Kaohsiung Medical University, Kaohsiung Veterans General Hospital., Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital, Taipei Veterans General Hospital, Taiwan