Genetic TestingNCT02742116
Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong
An observational study of Genetic Testing, run by The University of Hong Kong.
Trial summary
The objectives are to: 1. Assess patient's views and preferences in receiving expanded carrier screening 2. Perform qualitative study on post testing counselling on screen positive individuals and at risk couples Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Testing
- What is being tested?
- DNA screening before Pregnancy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both female and male Chinese participants are being studied
Who may be able to join
- Ethnic Chinese couples who attend prepregnancy clinic
- Age 18 or above
Who cannot join
- Couples who cannot read or understand Chinese or English
About this study
The objectives are to:
- Assess patient's views and preferences in receiving expanded carrier screening
- Perform qualitative study on post testing counselling on screen positive individuals and at risk couples
Read the detailed description
This study is to recruit 50 couples for Expanded carrier screening at Prepregnancy Checkup Clinic at the Family Planning Association.
Saliva swabs are collected from couples for Hereditary Disease DNA screening test by DrGene.
Blood samples are taken by venipuncture of women for Fragile X carrier screening by Prenatal Diagnostic Laboratory, Tsan Yuk Hospital.
A pre-test self-administered Questionnaire 1 will be administered to couples to assess their knowledge, views and preferences in receiving expanded carrier screening. This include collection of basic demographic information, answers to questions on basic principles of expanded carrier testing, reasons of having or declining the test, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level of the patient is assessed by state-trait anxiety inventory. Their willingness to pay for the test is also assessed.
The test results will be available to couples in 6 week's time. A post-test self-administered questionnaire 2 will be administered to couples on receiving the test results at the clinic. These include assessment of anxiety level, any decision regret, outcome of test and resulting action.
The couples with a screen positive result will be referred to Queen Mary Hospital for a joint counselling by clinical geneticist and gynaecologist. This counselling/consultation shall be audiotaped or videotaped. The interviews will be transcribed verbatim. The data will be explored for themes and issues identified.
Statistics Questionnaire survey data shall be entered into SPSS. Descriptive statistics will be used to compare responses and choices of participants.
- Conditions
- Genetic Testing
- Being tested
- DNA screening before Pregnancy
- Keywords
- Expanded carrier screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA screening before PregnancyGenetic
Saliva/swab shall be collected from couple for Hereditary Disease DNA screening test. Blood sample shall be taken by venipuncture of women for Fragile X carrier screening A pre-test questionnaire will be conducted to assess subject's knowledge, views and preferences in receiving expanded carrier screening, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level, and their willingness to pay for the test.
A post-test self-administered questionnaire shall be filled in by the patient on receiving the test results.
Couples who receive a screen positive result shall be subsequently referred to Queen Mary Hospital for joint counselling by clinical geneticist and gynaecologist. This consultation shall be audiotaped or videotaped.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient acceptance and literacy of expanded carrier screening
Factors affecting the choice of expanded carrier screening in the prepregnancy and subfertility patients Identify counselling issues when expanded carrier screening is offered in the local setting
Measured: 6 weeks
Secondary outcomes (1)
Patient acceptance and literacy of expanded carrier screening
cost, false positives, workload generated from offering expanded carrier screening
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic TestingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Grace CY Wong, MD, Principal investigator, The Family Planning Association of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742116
- Sponsor's protocol ID
- ECSFPA1.0
- Status last verified
- Nov 2016
- First submitted
- 13 Apr 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong
- ClinicalTrials.gov ID
- NCT02742116
- Acronym / sponsor ID
- ECSFPA1.0
- Conditions
- Genetic Testing
- Keywords
- Expanded carrier screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Apr 2016 (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.
The objectives are to:
- Assess patient's views and preferences in receiving expanded carrier screening
- Perform qualitative study on post testing counselling on screen positive individuals and at risk couples
Detailed description
This study is to recruit 50 couples for Expanded carrier screening at Prepregnancy Checkup Clinic at the Family Planning Association.
Saliva swabs are collected from couples for Hereditary Disease DNA screening test by DrGene.
Blood samples are taken by venipuncture of women for Fragile X carrier screening by Prenatal Diagnostic Laboratory, Tsan Yuk Hospital.
A pre-test self-administered Questionnaire 1 will be administered to couples to assess their knowledge, views and preferences in receiving expanded carrier screening. This include collection of basic demographic information, answers to questions on basic principles of expanded carrier testing, reasons of having or declining the test, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level of the patient is assessed by state-trait anxiety inventory. Their willingness to pay for the test is also assessed.
The test results will be available to couples in 6 week's time. A post-test self-administered questionnaire 2 will be administered to couples on receiving the test results at the clinic. These include assessment of anxiety level, any decision regret, outcome of test and resulting action.
The couples with a screen positive result will be referred to Queen Mary Hospital for a joint counselling by clinical geneticist and gynaecologist. This counselling/consultation shall be audiotaped or videotaped. The interviews will be transcribed verbatim. The data will be explored for themes and issues identified.
Statistics Questionnaire survey data shall be entered into SPSS. Descriptive statistics will be used to compare responses and choices of participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both female and male Chinese participants are being studied
Key inclusion criteria (2 listed)
- Ethnic Chinese couples who attend prepregnancy clinic
- Age 18 or above
Key exclusion criteria (1 listed)
- Couples who cannot read or understand Chinese or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA screening before PregnancySaliva/swab shall be collected from couple for Hereditary Disease DNA screening test. Blood sample shall be taken by venipuncture of women for Fragile X carrier screening A pre-test questionnaire will be conducted to assess subject's knowledge, views and preferences in receiving expanded carrier screening, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level, and their willingness to pay for the test. A post-test self-administered questionnaire shall be filled in by the patient on receiving the test results. Couples who receive a screen positive result shall be subsequently referred to Queen Mary Hospital for joint counselling by clinical geneticist and gynaecologist. This consultation shall be audiotaped or videotaped. | Genetic | – |
Primary outcome
Patient acceptance and literacy of expanded carrier screening
Time frame: 6 weeks
Factors affecting the choice of expanded carrier screening in the prepregnancy and subfertility patients Identify counselling issues when expanded carrier screening is offered in the local setting
1 secondary outcome
Patient acceptance and literacy of expanded carrier screening
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Grace CY Wong, MD principal investigator
The Family Planning Association of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Testing, run by The University of Hong Kong.
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 2 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: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient acceptance and literacy of expanded carrier screening (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2016.