Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

Gastrointestinal Cancer Clinical Trial

Official title:

Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00716209
• Other study ID #: NUSIRB 04-116
• Status: Active, not recruiting
• Phase: N/A
• First received: July 14, 2008
• Last updated: March 3, 2014
• Start date: September 2012

Study information

• Verified date: March 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Haematology-Oncology

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Mattison LK, Soong R, Diasio RB. Implications of dihydropyrimidine dehydrogenase on 5-fluorouracil pharmacogenetics and pharmacogenomics. Pharmacogenomics. 2002 Jul;3(4):485-92. Review. — View 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. — View 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. — View Citation