Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00716209
First received: July 14, 2008
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The proposal seeks to establish:

  • A comprehensive compilation (database) of clinical information comprising clinical, histopathological, treatment and follow-up characteristics of past and future gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators. The characteristics will include clinical (eg age, sex, stage), histopathological (eg. grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival, toxicity) from medical records.
  • A collection (bank) of corresponding frozen and fixed tissue, blood and processed samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in Singapore that can be shared by the investigators.
  • A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists researching prognostic and predictive markers in GIC, which will benefit from the multi-disciplinary knowledge, information and samples of its members.
  • To characterise genetic polymorphisms related to Gastrointestinal cancer chemotherapy treatment in controls (healthy volunteers)

Condition
Gastrointestinal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Study Start Date: September 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

To examine associations between candidate markers and patient response, toxicity and other clinicopathological characteristics, standard descriptive statistics will be used, according to the variable type (e.g. continuous, discrete, parametric, non-parametric). Associations with patient outcome will be assessed by Kaplan Meier analysis and independence examined in multivariate models by Cox proportional hazard analysis. To discriminate prognostic and predictive significance, outcome associations of candidate markers will be examined with respect to the treatment status of cohorts as outlined in the "Introduction" and as performed previously.

Criteria

Inclusion Criteria:

  • Patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal)

Exclusion Criteria:

  • None
  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: NCT00716209

Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
Haematology-Oncology
Investigators
Principal Investigator: Ross Andrew Soo, MBBS National University Hospital, Singapore
Principal Investigator: Alex Chang Johns Hopkins University
Principal Investigator: Chung Yip Chan Tan Tock Seng Hospital
  More Information

Publications:
Responsible Party: Haematology-Oncology, Ross Andrew Soo, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00716209     History of Changes
Other Study ID Numbers: NUSIRB 04-116
Study First Received: July 14, 2008
Last Updated: March 3, 2014
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014