Clinical trial NCT00716209: Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers
Official title: Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2008-07-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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)


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Ross Andrew Soo, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Singapore International Medical Centre
name: Alex Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: Tan Tock Seng Hospital
name: Chung Yip Chan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.