Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

March 3, 2014 updated by: Haematology-Oncology

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)

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haematology-Oncology

Investigators

  • Principal Investigator: Alex Chang, Johns Hopkins Singapore International Medical Centre
  • Principal Investigator: Chung Yip Chan, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUSIRB 04-116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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