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Familial Cancer Registry and DNA Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National University Hospital, Singapore
Sponsor:
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT02083224
First received: March 4, 2014
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition
Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Familial Cancer Registry and DNA Bank

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Change in genetics testing method [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 2000
Study Start Date: January 2000
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cancer patients

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

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:

Nil

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083224

Contacts
Contact: Soo Chin Lee, MBBS, MRCP +65 6779 5555 Soo_Chin_Lee@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Soo Chin Lee, MBBS, MRCP    +65 6779 5555    Soo_Chin_Lee@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Soo Chin Lee, MBBS, MRCP National University Hospital, Singapore
  More Information

Publications:
Responsible Party: Haematology-Oncology, Lee Soo Chin, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02083224     History of Changes
Other Study ID Numbers: 2000/00511
Study First Received: March 4, 2014
Last Updated: March 6, 2014
Health Authority: Singapore: Domain Specific Review Boards

ClinicalTrials.gov processed this record on November 27, 2014