NCT02083224

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

18.9 years

First QC Date

March 4, 2014

Last Update Submit

March 6, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in genetics testing method

    2 years

Study Arms (1)

Cancer patients

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are recruited from the National University Hospital. All cancer patients seen in the Cancer Centre, NUH, are screened using a basic family history form.The family history is reviewed by the Principal Investigator with the cancer genetics counselor. Eligible patients who fulfil the eligibility criteria as described below are invited to participate. Written informed consent is obtained. Demographic characteristics and cancer history of the study subject is prospectively recorded. Participants are invited to fill out a family history questionnaire providing cancer history information on their first- and second-degree relatives. Participants are also invited to donate 10ml blood for DNA banking and future genotyping. Permission will be obtained from participants to contact family members who may be eligible to participate in the study.

You may qualify if:

  • 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

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

  • 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. doi: 10.1002/(sici)1097-0142(19991201)86:11+3.0.co;2-8.

    PMID: 10630180BACKGROUND
  • 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. doi: 10.1056/NEJM199703203361202.

    PMID: 9062090BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood for DNA banking and future genotyping Questionnaires regarding family history of cancer and personal medical history will be taken.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Soo Chin Lee, MBBS, MRCP

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Chin Lee, MBBS, MRCP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lee Soo Chin

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

January 1, 2000

Primary Completion

December 1, 2018

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations