search
Back to results

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

Primary Purpose

Obesity, Colorectal Cancer, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Faecal Immunochemical Test
Prostate-Specific Antigen Test
Mammogram
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obesity focused on measuring Cancer Screening, Colorectal Cancer, Breast Cancer, Prostate Cancer, Obesity, Obesity-related Cancer, Multi-Cancer Screening

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Lek Yuen Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Colorectal Cancer Screening

Prostate Cancer Screening

Breast Cancer Screening

Arm Description

Potential 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.

A 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.

Up 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).

Outcomes

Primary Outcome Measures

Colorectal cancer detection rate
Evaluate the effectiveness of CRC screening in a one-stop community based obesity-related cancers screening program
Prostate cancer detection rate
Evaluate the effectiveness of prostate cancer screening in a one-stop community based obesity-related cancers screening program
Breast cancer detection rate
Evaluate the effectiveness of breast cancer screening in a one-stop community based obesity-related cancers screening program

Secondary Outcome Measures

Full Information

First Posted
April 16, 2019
Last Updated
October 8, 2020
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04034953
Brief Title
Prevention of Obesity-related Cancers: Setting up of a Multi-Cancer Education and Prevention Program in Hong Kong
Official Title
Prevention of Obesity-related Cancers: Setting up of a Multi-Cancer Education and Prevention Program in Hong Kong
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Colorectal Cancer, Prostate Cancer, Breast Cancer
Keywords
Cancer Screening, Colorectal Cancer, Breast Cancer, Prostate Cancer, Obesity, Obesity-related Cancer, Multi-Cancer Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colorectal Cancer Screening
Arm Type
Other
Arm Description
Potential 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.
Arm Title
Prostate Cancer Screening
Arm Type
Other
Arm Description
A 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.
Arm Title
Breast Cancer Screening
Arm Type
Other
Arm Description
Up 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Faecal Immunochemical Test
Other Intervention Name(s)
FIT
Intervention Description
Faecal Immunochemical Test detects if there is any hemoglobin presents in stools, so even tiny amount of blood in stool can be found.
Intervention Type
Diagnostic Test
Intervention Name(s)
Prostate-Specific Antigen Test
Other Intervention Name(s)
PSA
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Mammogram
Other Intervention Name(s)
MMG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Colorectal cancer detection rate
Description
Evaluate the effectiveness of CRC screening in a one-stop community based obesity-related cancers screening program
Time Frame
5 Years
Title
Prostate cancer detection rate
Description
Evaluate the effectiveness of prostate cancer screening in a one-stop community based obesity-related cancers screening program
Time Frame
5 Years
Title
Breast cancer detection rate
Description
Evaluate the effectiveness of breast cancer screening in a one-stop community based obesity-related cancers screening program
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas YT Lam
Phone
(852)26031407
Email
thomaslam@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph JY Sung
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lek Yuen Health Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas YT Lam
Phone
26031407
Email
thomaslam@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33718212
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs