CancerNCT02083224
Familial Cancer Registry and DNA Bank
An observational study of Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,000 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2000to Dec 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119074
Soo Chin Lee, MBBS, MRCP, +65 6779 5555, Soo_Chin_Lee@nuhs.edu.sg
About this study
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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in genetics testing method
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJan 2000
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haematology-Oncology, National University Hospital, Singapore
- Investigators
- Soo Chin Lee, MBBS, MRCP, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083224
- Sponsor's protocol ID
- 2000/00511
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10630180Giardiello 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.
PubMed 9062090
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Cancer Registry and DNA Bank
- ClinicalTrials.gov ID
- NCT02083224
- Acronym / sponsor ID
- 2000/00511
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2018 (estimated)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | – |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in genetics testing method
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
- Background: PubMed 10630180Petersen 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.
- Background: PubMed 9062090Giardiello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Chin Lee, MBBS, MRCP principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Chin Lee, MBBS, MRCP (+65 6779 5555, Soo_Chin_Lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in genetics testing method (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.