A clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/ or other pharmacodynamic effects of an investigational product(s) such as drug, vaccine or medical device with the objective of determining its safety and efficacy.
All clinical trials in Singapore must be reviewed and approved by an Ethics Committee and the Health Sciences Authority. The oversight by the ethics and regulatory bodies ensures that research is carried out in a safe and ethical manner.
Division of Obstetrics & Gynaecology
Division of Clinical Support Services
Division of Paediatrics Medicine
Division of Surgery
There are many different ways to participate in clinical trials at KK Women’s and Children’s Hospital. Volunteers may be healthy, at risk for developing a disease, or already diagnosed with a disease or illness. You can agree to be in a trial, give permission to have your medical record reviewed for research, or you can give permission for use of your blood and tissue samples.
For Research Volunteers
The following research studies in KKH are currently recruiting research volunteers. If you are interested to participate as a volunteer for our clinical research or would like to find out more on the research study, please contact us at the following contact information below.
1. A single arm Phase-IV study to determine reactogenicity and immunogenicity of delayed COVID-19 vaccine schedule in children
Principal InvestigatorDr Yung Chee Fu, Infectious Disease Service
Recruitment PeriodUntil 31/12/2023
Purpose of the researchTo study the COVID-19 vaccine response in children and evaluate the safety and immune response of an extended 2 months gap between doses versus a 3 weeks gap
Research procedures / visits requiredParticipation in the study includes 6 visits with blood sampling over 15 -18 months. The research study also requires parents/ caregivers of the participants to complete online vaccine side-effect diary on a daily basis for up to 7 days post-vaccination, update online any COVID-19 infection or positive ART test on a monthly basis.
Eligibility Criteria
Contact InformationEmail: ren.mee.hiong@singhealth.com.sg
Principal Investigator
Dr Saumya Jamuar, Genetics Service
Recruitment Period
Until 30/12/2024
Purpose of the research
The overarching aim of this study is to understand the utility of newer genomic technologies in understanding Mendelian disorders. This will be achieved by recruiting patients with Mendelian disorders; identifying associated genes by performing whole genome, exome or targeted next generation sequencing; followed by analysis of the results for candidate mutations.
Research procedures / visits required
Participants will be examined by a clinical geneticist and their clinical and dysmorphic features will be noted. Clinical information collected; physical examinations, and neurologic and behavioural signs too. After the clinical examination, other tests and consultations with other paediatric specialties may be ordered as necessary. 3-5ml of bloods from patients who have not had an identified genetic abnormality and who consent to the study will be included in this study.
Patients who fulfill criteria for Mendelian disorders and do not have a known molecular genetic diagnosis will be included in this study. (Mendelian disorders, for the purposes of this study, are defined as disorders occurring in families with a pattern that reflects the inheritance of a single causative gene. The list of Mendelian disorders includes, but is not limited to, patients with developmental delay, intellectual disability, autism spectrum disorders, craniosynostosis, skeletal dysplasia, and/or inherited cardiac disorders.)
Contact Information
Email: sd.genomic.medicine@singhealth.com.sg
3. Characterizing facial variations of individuals of Asian ancestry to aid in diagnostics of patients with genetic and rare diseases and syndromes
Until 30/12/2023
There are hundreds of conditions with facial clues. This study uses 3D photography to create tools to help diagnose these conditions & seeks to improve knowledge base for diagnosis of undiagnosed patients & treatment effects of diagnosed patients. Photographs of up to 1500 unaffected individuals will be captured per year.
Clinical information would be collected from the participant during their clinical consultation with the physician. This will be utilized for study data analysis. Photographs will be taken and analysed using a computer program that will produce statistical data points of the facial measurements. At no time will the photographic image itself be analysed or scrutinised. The affected or unaffected family members who have been offered imaging, will have to visit KKH separately for consent and photo taking.
Any child/family member who provides consent to participate in the study.
4. Healthy Early Life Moments in Singapore (HELMS)
Prof Chan Kok Yen Jerry, Reproductive Medicine
Until 31/08/2023
The HELMS programme aims to optimise women's metabolic health and mental wellness to
There will be 2 visits (if pregnant) or 3 visits (if non-pregnant over 1-year) during the preconception phase, 3 visits during the pregnancy phase that coincide with routine antenatal visits, and 6 visits during the postnatal phase coinciding with the child vaccination time points.
Body measurements, lifestyle assessments, and bio-specimen collection will be conducted for the participants. The participants will receive over-the-counter micronutrients supplements, education on care and healthy lifestyles at different phases. They will also be given food diary and self-administer an online nutrition intervention tool, known as the 6P tool to monitor their dietary behavior. Participants will also receive exercise guidance, an accelerometer and a sleep tracker to track for 24-hour activity.
Email: helms@kkh.com.sg
Contact No: 80444556
5. FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors
Dr Enrica Tan Ee Kar, Haematology Oncology Service
Until 30/04/2024
To evaluate the response rate in pediatric patients with relapsed/progressive low-grade glioma or advanced solid tumors following treatment with DAY101.
The study consists of a screening period, treatment period as well as follow-up assessments. Recruited patients will be asked to take DAY101 once a week at home, and will come once every 28 days, over a 26-month period, for research procedures such as blood tests, ECG, ECHO and MRI.
Email: Sameema.n.haja.mohideen@kkh.com.sg
Contact No: 6394 7760
6. Asia-wide, multicenter open-label, phase II non-randomised study involving children with Down syndrome under 21 year-old with newly diagnosed, treatment naïve acute lymphoblastic leukemia (ASIA DS-ALL 2016)
A/Prof Tan Ah Moy, Haematology Oncology Service
The overall objective of this study is to improve the treatment outcome for Down syndrome children with ALL (DS-ALL) using multi-agent chemotherapy. The treatment protocol is modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.
The overall treatment plan for childhood ALL is divided into 3 phases:
1) Induction phase in the first 5 weeks to reduce the leukemia to a very low level followed by
2) Consolidation and re-induction phase lasting for 12-18 months, and finally
3) A milder chemotherapy phase called maintenance will last for about 2 years with the intention of making the leukemia stay in remission long term.
In this study, the treatment that the participant receives will be based on their risk assignment. Participants will be assigned to either low risk (LR) or standard risk (SR) group based on the presenting features at diagnosis and his/her subsequent treatment response. Participants will be followed up yearly for at least 5 years upon completion of study therapy.
Email: germaine.liew.shimin@singhealth.com.sg
Contact No: 6394 5025
7. Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to improve risk assignment in childhood, adolescent, and young adult acute lymphoblastic leukaemia
Until 28/02/2025
The purpose of the research is to find out whether adjusting treatment according to patient's genetic subtype of leukemia and response to initial treatment, will help maintain the optimal chance of cure while minimizing side-effects, and to find out how the patient's genes affect the response and side effects of treatment.
The patients will be assigned to one of three risk groups; standard risk, intermediate risk, or high risk. Risk assignment will be based on minimal residual disease during the treatment, genetic markers, and age at diagnosis. The study treatment will be administered in 5 distinct phases; Induction, Consolidation, Delayed Intensification, Interim Maintenance, and Maintenance. The treatment duration lasts about 2 years, after which the patient will be followed up yearly for another 5 years.
8. Paediatric Hepatic International Tumour Trial (PHITT)
Dr Soh Shui Yen, Haematology Oncology Service
Until 31/12/2025
The PHITT trial is an international multi-centre over-arching study for paediatric patients with liver cancers - Hepatoblastoma (HB) and Hepatocellular carcinoma (HCC), and builds on the cooperative experience of the key childhood liver tumour consortia (SIOPEL, COG, JPLT, GPOH).
Participants will undergo biopsy/surgery to get a histologically confirmed diagnosis prior to trial entry. To determine eligibility for treatment, screening assessments such as clinical evaluation, radiological scans, laboratory tests, hearing and cardiac assessments will be carried out. Clinical data will be collected and sent for central radiology/pathology review. Participants diagnosed with HB will be stratified into four risks groups: Group A (very low risk), Group B (low risk), Group C (intermediate risk) and Group D (high risk); while participants diagnosed with HCC will be divided into two groups: Group E (resectable HCC) and Group F (unresectable and/or metastatic HCC). Further randomisation for participants in Group B, C, D and F will be performed to allocate their treatment. At the end of treatment, participants will have follow-up examinations and medical tests for a minimum of 3 years.
Trial Entry Inclusion Criteria
Treatment Allocation Inclusion Criteria
Email: lye.chun.lin@kkh.com.sg
Contact No: 6394 1636
9. Lifestyle interventions to prevent postpartum Type 2 Diabetes in Asian women with a history of gestational diabetes mellitus (Integrated Hyperglycaemia Incentivised Postnatal Surveillance (I-HIPS) Study)
Prof Tan Kok Hian, Maternal Fetal Medicine
Until 31/7/2023
This study aims to conduct a lifestyle intervention trial on early postpartum women with a history of GDM to test the feasibility, efficacy and cost-effectiveness of an intervention approach in preventing women with gestational diabetes (GDM) from developing Type 2 Diabetes (T2D).
All eligible participants will be randomized into one of two groups – The Wearable Care Group or the Scheduled Care Group. All participants will undergo a metabolic health profile check at the baseline visit by assessing their blood pressure, body mass index (BMI) and bloods for HbA1C levels and fasting lipid profile. During the entire duration of the trial, all participants will be receiving close follow-up care, consultations with our Obstetricians & Gynecologists and transport reimbursements. There will be 8 study visits in total with one baseline recruitment visit, and 7 follow-up study visits. Those placed in the Wearable Care group will receive additional wearable devices (continuous glucose monitoring (CGM) and an exercise tracker), as well as guided nutrition and exercise workshops.
Inclusion Criteria:
Exclusion Criteria:
Email: ipramho@kkh.com.sg
Contact No: 8223 2674
10. The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: A Randomized Controlled Trial
Dr Ee Tat Xin, Reproductive Medicine
Until 31/10/2023
The purpose of the study is to determine the effectiveness of this Bu Shen Yi Jing (BSYJ) pills, a TCM formulation, to see if it can help boost fertility by improving sperm parameters, and eventually help your wife conceive a baby.
We will be randomizing into 2 groups, meaning you will be receiving either the actual pill or a placebo pill. Over this period, there will be a total of 6 visits every three months to KKH. To join this study, we will need you to come down to KKH first for a screening visit to see if you are eligible for the study.
1. Looking for Male participants
2. Trying for a baby for >1 year
3. Aged 21 – 49 years old
4. Not taking any fertility supplements
5. Abnormal semen analysis results
Email: Erica.n.fadziulah@singhealth.com.sg
Contact No: 63947201
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