Familial Cancer Registry and DNA Bank

Cancer Clinical Trial

Official title:

Familial Cancer Registry and DNA Bank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02083224
• Other study ID #: 2000/00511
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2014
• Last updated: March 6, 2014
• Start date: January 2000

Study information

• Verified date: March 2014
• Source: National University Hospital, Singapore
• Contact: Soo Chin Lee, MBBS, MRCP
• Phone: +65 6779 5555
• Email: Soo_Chin_Lee[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Clinical cancer genetics is an emerging new field in medical oncology, and has been incorporated into routine oncology practice in many leading medical institutions in North America and Europe. Cancer genetics is the study of genetic factors contributing to carcinogenesis. In the last 5-10 years, genes responsible for various well-defined hereditary cancer syndromes have been cloned. These include the BRCAJ/2 genes in hereditary breast and ovarian cancer syndrome, the A4PC gene in Familial Adenomatous Polyposis, and the mismatch repair genes (hMLH1, hMSH2, hPMS1, hPMS2, hMSH6) in hereditary non-polyposis colorectal cancer (HNPCC). One of the goals of a clinical cancer genetics service is to identify families at risk for hereditary cancer syndromes, provide genetic counseling, and offer genetic testing when appropriate. The identification of causative genes in hereditary cancer syndromes together with the advent of genetic testing is starting to have an impact on clinical management. The ability to identify a gene mutation in a cancer family allows predictive testing, stratifying at-risk family members into carriers who will benefit from aggressive surveillance and/or preventive options, and non-carriers who may be spared unnecessary surveillance. Appropriate use of genetic testing will ultimately result in medical cost reduction.

The investigators hypothesize that the clinical characteristics and genetic factors contributing to hereditary cancer in the Singaporean Asian population are distinct from those described for Western patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Any individual with very early onset cancer (eg diagnosed before age 40).

• Any family with three or more first- or second-degree relatives with the same cancer

• Any individual with two or more different primary cancers

• Any family that fulfils diagnostic criteria for known hereditary cancer syndromes

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Giardiello FM, Brensinger JD, Petersen GM, Luce MC, Hylind LM, Bacon JA, Booker SV, Parker RD, Hamilton SR. The use and interpretation of commercial APC gene testing for familial adenomatous polyposis. N Engl J Med. 1997 Mar 20;336(12):823-7. — View Citation

Petersen GM, Brensinger JD, Johnson KA, Giardiello FM. Genetic testing and counseling for hereditary forms of colorectal cancer. Cancer. 1999 Dec 1;86(11 Suppl):2540-50. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in genetics testing method		2 years	No