NCT00716209

Brief Summary

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)

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
4.1 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

2.2 years

First QC Date

July 14, 2008

Last Update Submit

March 3, 2014

Conditions

Gastrointestinal Cancer

Study Arms (1)

1

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (3)

  • Soong R, Robbins PD, Dix BR, Grieu F, Lim B, Knowles S, Williams KE, Turbett GR, House AK, Iacopetta BJ. Concordance between p53 protein overexpression and gene mutation in a large series of common human carcinomas. Hum Pathol. 1996 Oct;27(10):1050-5. doi: 10.1016/s0046-8177(96)90282-8.

    PMID: 8892589BACKGROUND

  • Soong R, Powell B, Elsaleh H, Gnanasampanthan G, Smith DR, Goh HS, Joseph D, Iacopetta B. Prognostic significance of TP53 gene mutation in 995 cases of colorectal carcinoma. Influence of tumour site, stage, adjuvant chemotherapy and type of mutation. Eur J Cancer. 2000 Oct;36(16):2053-60. doi: 10.1016/s0959-8049(00)00285-9.

    PMID: 11044641BACKGROUND

  • Mattison LK, Soong R, Diasio RB. Implications of dihydropyrimidine dehydrogenase on 5-fluorouracil pharmacogenetics and pharmacogenomics. Pharmacogenomics. 2002 Jul;3(4):485-92. doi: 10.1517/14622416.3.4.485.

    PMID: 12164772BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Ross Andrew Soo, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

  • Alex Chang

    Johns Hopkins Singapore International Medical Centre

    PRINCIPAL INVESTIGATOR

  • Chung Yip Chan

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ross Andrew Soo

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

SG(1)