NCT04034953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

April 16, 2019

Last Update Submit

October 8, 2020

Conditions

Keywords

Cancer ScreeningColorectal CancerBreast CancerProstate CancerObesityObesity-related CancerMulti-Cancer Screening

Outcome Measures

Primary Outcomes (3)

  • Colorectal cancer detection rate

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

    5 Years

  • Prostate cancer detection rate

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

    5 Years

  • Breast cancer detection rate

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

    5 Years

Study Arms (3)

Colorectal Cancer Screening

OTHER

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.

Diagnostic Test: Faecal Immunochemical Test

Prostate Cancer Screening

OTHER

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.

Diagnostic Test: Prostate-Specific Antigen Test

Breast Cancer Screening

OTHER

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).

Diagnostic Test: Mammogram

Interventions

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

Also known as: FIT
Colorectal Cancer Screening

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.

Also known as: PSA
Prostate Cancer Screening
MammogramDIAGNOSTIC_TEST

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.

Also known as: MMG
Breast Cancer Screening

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lek Yuen Health Centre

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityColorectal NeoplasmsProstatic NeoplasmsBreast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Joseph JY Sung

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

July 29, 2019

Study Start

August 6, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

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.

Locations