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ObesityNCT04034953

Prevention of Obesity-related Cancers: Setting up of a Multi-Cancer Education and Prevention Program in Hong Kong

A study testing Faecal Immunochemical Test, Prostate-Specific Antigen Test and Mammogram in people with Obesity and Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Obesity could increase the risk of many chronic diseases, including hypertension, cardiovascular diseases, high lipid level, diabetes, stroke, endometrial cancer and certain types of cancer which could benefit by secondary prevention through screening programs. Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Colorectal Cancer, Prostate Cancer
What is being tested?
Faecal Immunochemical Test, Prostate-Specific Antigen Test and Mammogram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,000 participants
Where
1 siteHong Kong
Study dates
6 Aug 2018to 31 Dec 2023
Phase
Interventional
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 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 40 to 75 years depending on risk factor(s);
  • Measured BMI ≥ 25 kg/m2; or waist circumference >80cm [women] or >90 cm [men]; and
  • Absence of existing or previous symptoms suggestive of CRC and breast cancer

Who cannot join

  • Having received updated CRC screening tests (FIT in the past 2 year; flexible sigmoidoscopy in the past 5 years; colonoscopy in the past 10 years);
  • Having received updated prostate or breast screening test in the past 2 years;
  • Having personal of CRC, prostate or breast cancers;
  • Having personal history of colonic adenoma, diverticular disease or inflammatory bowel disease;
  • Having medical conditions which were contraindications for colonoscopy, like cardiopulmonary insufficiency and the use of double antiplatelets, etc.; and
  • Having medical conditions and disabling conditions with limited life expectancy

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting
  • Lek Yuen Health Centre

    Hong Kong

    Thomas YT Lam, 26031407, thomaslam@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Obesity could increase the risk of many chronic diseases, including hypertension, cardiovascular diseases, high lipid level, diabetes, stroke, endometrial cancer and certain types of cancer which could benefit by secondary prevention through screening programs. The World Cancer Research Fund of the American Institute for Cancer Research has reviewed all the studies about the link between obesity and cancer. Studies shown that obesity is an independent risk factor for colorectal, breast and prostate cancer. These three cancers (will be named as "obesity-related cancers" thereafter) demonstrate a rapidly increasing trend of incidence in Asia in the past decade.

Among Chinese adults of Hong Kong in 2014, 39% were overweight or obese (compared with 20.9% reported in European adults in the same year) and up to 69.7% reported that they did not perform any measures to achieve optimal weight control. Men (49.6%) had a higher proportion of overweight or obesity than females (29.5%). Adults who are aged 45-54 had the highest rate (50.5%) of overweight or obesity than other age groups. In addition, there were 62.5% whose physical activity level did not meet the recommendations from the World Health Organization (WHO). Only 18.7% consumed at least 5 portions of fruit and vegetables per day; yet about 30% were alcoholic drinkers; and more than 10% were daily or occasional smoker. These figures imply that the incidence of obesity and obesity-related cancers will further escalate - and urgent actions at the community level are needed to combat the rising incidence and mortality of these conditions.

Read more

According to Hong Kong Cancer Registry, the discrepancy between the number of new cases (incidence) and number of deaths (mortality) is much higher for colorectal, breast and prostate cancer as compared to other cancers. It is well recognized that screening could effectively reduce mortality for these three obesity-related cancers when they are detected at an earlier stage.

The concept of a one-stop approach to screen for multiple cancers was found to be feasible, with an ability to detect a wide range of neoplastic lesions at an early stage. In the recent decade, there are also emerging centres that have been established as multi-cancer screening clinics worldwide. Nevertheless, there is a scarcity of studies that have highlighted the outcomes of these multi-cancer screening programs.

Read the detailed description

Obesity could increase the risk of many chronic diseases, including hypertension, cardiovascular diseases, high lipid level, diabetes, stroke, endometrial cancer and certain types of cancer which could benefit by secondary prevention through screening programs. In particular, colorectal, breast and prostate cancer (these three cancers will be named as "obesity-related cancers" thereafter) demonstrate a rapidly increasing trend of incidence in Asia in the past decade. The World Cancer Research Fund of the American Institute for Cancer Research has reviewed all the studies about the link between obesity and cancer . For colorectal cancer (CRC), there is compelling evidence suggesting that obesity is associated with 30-66% higher risk of developing CRC. Weight gain during adulthood was also shown to increase risk of CRC. As for breast cancer, post-menopausal women with the smallest waist (compared with the largest) had 39% lower risk of getting breast cancer . A 5-unit increase in BMI is associated with 12% increased risk of breast cancer, and this figure escalates to 20-40% for postmenopausal women. For prostate cancer, greater body fatness has been suggested as a reason of advanced prostate cancer. Obesity was positively related to advanced stage prostate cancer. The relative risk is 1.09 for every 5 kg/m2 higher BMI.

Among Chinese adults of Hong Kong in 2014, 39% were overweight or obese (compared with 20.9% reported in European adults in the same year) and up to 69.7% reported that they did not perform any measures to achieve optimal weight control. Men (49.6%) had a higher proportion of overweight or obesity than females (29.5%). Adults who are aged 45-54 had the highest rate (50.5%) of overweight or obesity than other age groups. In addition, there were 62.5% whose physical activity level did not meet the recommendations from the World Health Organization (WHO). Only 18.7% consumed at least 5 portions of fruit and vegetables per day; yet about 30% were alcoholic drinkers; and more than 10% were daily or occasional smoker. These figures imply that the incidence of obesity and obesity-related cancers will further escalate - and urgent actions at the community level are needed to combat the rising incidence and mortality of these conditions.

As shown in Figure 2, the discrepancy between the number of new cases (incidence) and number of deaths (mortality) is much higher for colorectal, breast and prostate cancer as compared to other cancers. It is well recognized that screening could effectively reduce mortality for these three obesity-related cancers when they are detected at an earlier stage.

Primary prevention is one of the crucial strategies found to be effective in cancer prevention. Health education on modification of lifestyle factors is especially useful to change behavior and reduce the impact of the threats posed by obesity and its related cancers. The application of behavioral medicine, defined as "the interdisciplinary field concerned with the development and integration of sociocultural, psychosocial, behavioral, and biomedical knowledge relevant to health and illness and the application of this knowledge to disease prevention, health promotion, etiology, diagnosis, treatment, and rehabilitation'', has been considered to be the most effective and practical means to prevent cancers. A comprehensive strategy for reducing cancers also includes secondary prevention that aims at early detection of diseases. Early detection for some "screen-relevant" cancers is particularly effective to reduce cancer-related mortality.

The concept of a one-stop approach to screen for multiple cancers is relatively novel from existing literature - and one of such initiatives is the "Integrated Cancer Prevention Centre" (ICPC) established in Tel Aviv Sourasky Medical Center at Israel in 2006. Analysis of the first 1,000 subjects visiting the centre showed that the compliance at the centre was higher than those seen in the Ministry of Health for the general population (78% vs. 60% for mammography; 39% vs. 16% for colonoscopy). The provision of such a unique facility designed for one-stop screening for multiple cancers was found to be feasible, with an ability to detect a wide range of neoplastic lesions at an early stage. In the recent decade, there are also emerging centres that have been established as multi-cancer screening clinics worldwide. Nevertheless, there is a scarcity of studies that have highlighted the outcomes of these multi-cancer screening programs.

Being tested
Faecal Immunochemical Test, Prostate-Specific Antigen Test, Mammogram
Keywords
Cancer Screening, Colorectal Cancer, Breast Cancer, Prostate Cancer, Obesity, Obesity-related Cancer, Multi-Cancer Screening
Medical subject headings
Obesity, Colorectal Neoplasms, Prostatic Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Faecal Immunochemical TestDiagnostic test

    Also called FIT

    Faecal Immunochemical Test detects if there is any hemoglobin presents in stools, so even tiny amount of blood in stool can be found.

  • Prostate-Specific Antigen TestDiagnostic test

    Also called PSA

    PSA blood test is used to measure the level of PSA in blood. When the PSA level is higher than normal, it may represent prostate cancer or benign prostate hyperplasia. Patient who have high PSA level should receive additional tests.

  • MammogramDiagnostic test

    Also called MMG

    Each sides of breast will be taken imaging in 2 different views.The breast will be pressed between 2 plastic plates to flatten and spread the breast tissue for clear imaging.

Study groups in NCT04034953
Study groupRoleWhat they receive
Colorectal Cancer ScreeningOtherPotential screening participants will firstly be briefed about the CRC screening pilot program launched by the Department of Health (DH). This project will offer screening referrals to the government pilot program or FIT screening tests for a total of 10,000 consecutive visitors.
Receives: Diagnostic Test: Faecal Immunochemical Test
Prostate Cancer ScreeningOtherA blood test for Prostate Specific Antigen (PSA) will then be performed. Subsequently, for subjects with serum PSA 4-10 ng/ml, additional blood tests for Prostate Health Index (PHI) will be performed for the further assessment of risk of prostate cancer. Subjects with serum PSA > 10 ng/ml; or PHI ≥ 35 will be referred for Trans-rectal Ultrasound-guided Prostatic Biopsy (TRUS+PB). Subjects with serum PSA < 4 ng/ml or with PHI level < 35 will be invited to repeat the prostate screening tests every 2-years. We aim to screen not more than 5,000 subjects. For all patients recruited for prostate cancer screening, the study team will continue follow the subjects, by phone or mail or other means, for the long term clinical outcome for up to 10 years.
Receives: Diagnostic Test: Prostate-Specific Antigen Test
Breast Cancer ScreeningOtherUp to 5,000 eligible female subjects will receive a mammography on a 2-yearly basis. Individuals with abnormal findings on mammography will be referred for subsequent follow-up by the Jockey Club Breast Health Centre (BHC) run by the Hong Kong Breast Cancer Foundation (HKBCF).
Receives: Diagnostic Test: Mammogram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colorectal cancer detection rate

    Evaluate the effectiveness of CRC screening in a one-stop community based obesity-related cancers screening program

    Measured: 5 Years

  2. Prostate cancer detection rate

    Evaluate the effectiveness of prostate cancer screening in a one-stop community based obesity-related cancers screening program

    Measured: 5 Years

  3. Breast cancer detection rate

    Evaluate the effectiveness of breast cancer screening in a one-stop community based obesity-related cancers screening program

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start6 Aug 2018
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034953
Sponsor's protocol ID
MCP Study
Status last verified
Oct 2020
First submitted
16 Apr 2019
Last updated
12 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Access to the data or study record will be available to authorized research staff (eg, Principle Investigator, Co-Investigators, research assistant, etc) only, during and after the study.

Publications

  • Zhu Z, Lam TYT, Tang RSY, Wong SH, Lui RNS, Ng SSM, Wong SYS, Sung JJY. Triglyceride-glucose index (TyG index) is associated with a higher risk of colorectal adenoma and multiple adenomas in asymptomatic subjects. PLoS One. 2024 Nov 7;19(11):e0310526. doi: 10.1371/journal.pone.0310526. eCollection 2024.

    PubMed 39509387
  • Sung JJY, Luk AKC, Ng SSM, Ng ACF, Chiu PKF, Chan EYY, Cheung PSY, Chu WCW, Wong SH, Lam TYT, Wong SYS. Effectiveness of One-Stop Screening for Colorectal, Breast, and Prostate Cancers: A Population-Based Feasibility Study. Front Oncol. 2021 Feb 25;11:631666. doi: 10.3389/fonc.2021.631666. eCollection 2021.

    PubMed 33718212

Questions about this trial

What is this clinical trial studying?

A study testing Faecal Immunochemical Test, Prostate-Specific Antigen Test and Mammogram in people with Obesity and Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in 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 3 inclusion and 6 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 12 Oct 2020. 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 Hong Kong. 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 Thomas YT Lam ((852)26031407, thomaslam@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colorectal cancer detection rate (time frame: 5 Years). The study lists 3 primary outcomes in all. 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 NCT04034953, 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 12 Oct 2020.

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