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Pulling back the curtain on research trials

At the National Cancer Centre Singapore (NCCS), there are over 200 ongoing research trials. With more than 10 million deaths in 2020, and cancer incidence for both genders rising between 2014 to 2018 in Singapore, developing and trialling new cancer therapies is a focus for NCCS. 

While clinicians and researchers lead the trials and studies, dedicated research coordinators, administrators and laboratory technologists make their execution possible.

Salubris pulls back the curtain on two recently announced studies at NCCS to find out what it takes to conduct these studies and deliver innovative therapies to patients.

An elegant approach to diagnosing liver cancer

Only 20% of the primary liver cancer hepatocellular carcinoma (HCC) is diagnosed at a stage when curative treatment is possible. The progression of HCC is highly dependent on which stage the patient is diagnosed at and the timely initiation of therapy.

To address the need to diagnose HCC earlier, Professor Pierce Chow, Senior Consultant in the Division of Surgery and Surgical Oncology, Singapore General Hospital (SGH) and NCCS, and a team of investigators initiated a multi-centre study called ELEGANCE (EarLy DEtection of HCC: miRNA, microbiome and imaGing biomArkers in the evolution of chroNiC livEr Disease) in a high-risk prospective cohort. The team designed a protocol to recruit and study 2,000 participants at risk for HCC; individuals with liver cirrhosis, hepatitis B or C, non-alcoholic fatty liver disease or non-alcoholic steatohepatitis.

Work began as early as 2019. The conceptualisation of the study was followed by the grant application and finally, the grant award. As agreements with the 13 other recruitment sites (in addition to NCCS), two academic collaborators and three industry partners were being finalised, the research team set up the study. Three teams manage the study’s day-to-day operations; a support team that developed the study protocol with the investigators and submitted it for Institutional Review Board (IRB) approval, the research coordinators who liaise with the recruitment sites to streamline the process of patient recruitment and follow-up, and the laboratory team that sets up and manages the lab for sample processing and storage.

Recruitment started in April 2021 and the three teams continue to manage the study’s operations while continuously refining process.

In a study of this size, with so many touchpoints, the research team’s biggest challenge is ensuring that all collaborators share common objectives for the study. Their motivation is knowing that their work will enhance patient care, “Research studies are important for discovery and innovation. With the ELEGANCE study, we can expand on existing knowledge about hepatocellular carcinoma to improve care for the patients.”

The ELEGANCE research team meeting online, clockwise starting from top left, Lynette Lai, Sim Yuki, Ong Xiao Quan, Jade Goh Shu Qi, Jacelyn Chua, Wu Lingyan.

Using Traditional Chinese Medicine in cancer care

In September 2019, the HERBAL trial (HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing CRF using TraditionAL Chinese Medicine) was started to evaluate the benefit of using Traditional Chinese Medicine (TCM) to manage cancer-related fatigue. Cancer-related fatigue refers to a distressing and persistent sense of physical, emotional or cognitive tiredness frequently experienced by cancer survivors that can interfere with daily functioning. The trial is led by Dr Tira Tan, Consultant in the Department of Breast and Gynaecology, Division of Medical Oncology, NCCS.

Some of the herbs used in the modified TCM formula in the HERBAL trial, conducted at the National Cancer Centre Singapore. Credit: Singapore Thong Chai Medical Institution.

Edmund Wang joined the Oncology Pharmacy Research department in NCCS to be a research coordinator for the HERBAL trial because he wanted to be part of a study that would contribute to the understanding of TCM.

“Many people use TCM as an alternative therapy for managing cancer-related side effects on their own accord but there is little published medical literature on its use,” shared Edmund.

To recruit eligible patients for the trial, Edmund connects with oncologists in NCCS’ Division of Medical Oncology. Once the treating oncologist obtains the patient’s consent, Edmund follows-up to contact them and arranges for their first check-in.

At their first check-in, the whole research team plays a role. First, Edmund walks the patient through informed consent paperwork and confirms that they meet the eligibility criteria. He explains that the trial is double-blind with a possibility that they could receive a placebo. Then, Edmund administers questionnaires that aim to assess their quality-of-life, fatigue and cognition. Thereafter, the patient is reviewed by a TCM physician from the Singapore Thong Chai Medical Institution to see if they satisfy the criteria for having a qi and blood deficiency. Next, a nurse from NCCS’ Division of Supportive and Palliative Care conducts an assessment to establish their current health condition and a phlebotomist takes the patient’s blood to monitor their full blood count, kidney and liver function. Finally, Edmund gives the patient the medication or placebo as assigned by the trial. 

Faced with challenges in recruiting patients due to heightened COVID-19 measures, Edmund remains undeterred.

“Clinical trials are the first step before therapies are introduced. It is a key part of getting new therapies on the market, so the work that we do to assess the safety of a therapy is critical,” stressed Edmund.