Colorectal NeoplasmsNCT02038283
Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening
An observational study of Colorectal Neoplasms, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial summary
Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong Kong and the second leading cause of cancer death in this population. Several screening strategies has been associated with improved survival and may affect patients' health-related quality of life (HRQOL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- Type of treatment
- Injection or infusion
- How many people
- 587 participants
- Where
- 3 sitesHong Kong
- Study dates
- Oct 2009to Jun 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Chinese patients of 18 years old or above with a histology of confirmed colorectal polyp or cancer for at least six months were recruited from specialist outpatient medical and surgical colorectal clinics of Queen Mary hospital in Hong Kong.
Who may be able to join
- Age 18 years or above
- Have life expectancy of at least 6 months
- Have confirmed diagnosis of any of the following colorectal neoplasm classified by the screening surveillance guideline and UICC/AJCC (TNM) staging system
- Have given consent to take part in the study
Who cannot join
- Inability to understand or communicate in Cantonese or Chinese
- Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
- Too ill to carry out an interview
- Refuse to give consent
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Department of Clinical Oncology, Faculty of Medicine, The University of Hong Kong
Hong Kong Island
Department of Medicine, Queen Mary Hospital
Hong Kong Island
Department of Surgery, Faculty of Medicine, The University of Hong Kong
Hong Kong Island
About this study
Official title: A Study on Health-related Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening in Hong Kong
Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong Kong and the second leading cause of cancer death in this population. Several screening strategies has been associated with improved survival and may affect patients' health-related quality of life (HRQOL). HRQOL impact should be used to adjust for survival in terms of quality adjusted life years (QALY) in the evaluation of cost-effectiveness of any intervention including screening.
Objectives: to determine the HRQOL and health preference of patients with different stages of colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for increasing QALYs.
Read more
Design and Subjects: A longitudinal survey to collect data on HRQOL associated with colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified sample of 420 patients with colorectal polyps and different stages of CRC will be recruited from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment. The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference data will be integrated with cost and effectiveness data obtained from the literature to determine the cost-effectiveness of currently recommended CRC screening strategies by Markov modeling.
Main outcome measures: The primary outcome measure is the SF-6D health preference value and QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared between patients with different stages of colorectal neoplasm. Markov modeling study will estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC screening strategy.
Results: The study will provide information on HRQOL of patients with colorectal neoplasm to guide health services. The Markov Model will identify the most cost-effective CRC screening strategy for Hong Kong Chinese, which can inform policy makers and the public for the prevention of CRC of the population.
Read the detailed description
The aims are to determine the HRQOL and health preference (utility) of different stages of colorectal neoplasm in order to evaluate the cost-effectiveness of different CRC screening strategies for the Chinese population in Hong Kong.
The specific objectives are:
- To determine the HRQOL preference values of patients in different stage of colorectal neoplasm in order to estimate the quality of life adjustment applicable to each stage of colorectal neoplasm.
- To evaluate the HRQOL of patients with colorectal neoplasm in order to find out their concerns and needs.
- To find out whether HRQOL preference of people with colorectal neoplasm changes with time.
- To determine the expected life years gained from the reduction in the incidence and mortality rates of CRC for each CRC screening strategy base on literature review.
- To determine the QALY gained from each CRC strategy by combining the preference value with life years gained.
- To identify the most cost-effective CRC screening strategy and to determine the incremental cost per additional QALY gained compared to no screening, by Markov modelling.
The study hypotheses are:
- Patients with colorectal neoplasm including those with polyps have lower HRQOL than the general population.
- There is a gradient reduction in HRQOL preference among patients with different stages colorectal neoplasm from polyp to metastatic cancer.
- HRQOL preference of patients with colorectal neoplasm is stable if there is no change in the disease stage.
- Annual I-FOBT is the most cost-effective CRC screening strategy for the Chinese population in Hong Kong.
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Early Detection of Cancer, Quality of Life, Quality-Adjusted Life Years, Direct Service Costs, Cost-Benefit Analysis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk Colorectal Polyps | ≤2 adenomas or 3-4 adenomas all of which are <1cm | |
| High-risk Colorectal Polyps | ≥5 adenomas or ≥3 adenomas at least one of which is ≥1cm | |
| Stage I CRC | at least six months since diagnosis of Stage I CRC | |
| Stage II CRC | at least six months since diagnosis of Stage II CRC | |
| Stage III CRC | at least six months since diagnosis of Stage III CRC | |
| Stage IV CRC | at least six months since diagnosis of Stage IV CRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-6D Preference-based Value
HRQOL preference value measured by The Chinese (HK) SF-6D Health Survey was calculated by the HK population specific algorithm. It ranges from 0 (death) to 1 (perfect health).
Measured: Twelve months
Quality-adjusted life years for each screening strategy
The effectiveness of CRC screening is quantified by Quality-adjusted life years, which was calculated as the product of average duration of each health state (including no illness) and the SF-6D preference value for that particular health state.
Measured: Baseline
Direct Health Care Costs for each CRC screening strategy
The direct health care costs of different CRC screening strategies and treatments of different stages of CRC were estimated using the costs published by the Government Gazette.
Measured: Baseline
Secondary outcomes (3)
HRQOL by SF-12v2 and FACT-C
HRQOL measured by the SF-12v2 and FACT-C was evaluated to identify the major problems of life of CRC patients.
Measured: Twelve months
Health Service Utilizations
Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.
Measured: Baseline
Factors Associated with HRQOL
Factors including type of treatments that may affect HRQOL of patients with CRC were explored.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Principal investigator, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038283
- Sponsor's protocol ID
- HKCTR-973
- Status last verified
- May 2016
- First submitted
- 28 Aug 2013
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong CK, Lam CL, Law WL, Poon JT, Chan P, Kwong DL, Tsang J. Validity and reliability study on traditional Chinese FACT-C in Chinese patients with colorectal neoplasm. J Eval Clin Pract. 2012 Dec;18(6):1186-95. doi: 10.1111/j.1365-2753.2011.01753.x. Epub 2011 Aug 18.
PubMed 21851512Wong CK, Lam CL, Poon JT, McGhee SM, Law WL, Kwong DL, Tsang J, Chan P. Direct medical costs of care for Chinese patients with colorectal neoplasia: a health care service provider perspective. J Eval Clin Pract. 2012 Dec;18(6):1203-10. doi: 10.1111/j.1365-2753.2011.01776.x. Epub 2011 Nov 23.
PubMed 22111837Wong CK, Lam CL, Rowen D, McGhee SM, Ma KP, Law WL, Poon JT, Chan P, Kwong DL, Tsang J. Mapping the Functional Assessment of Cancer Therapy-general or -Colorectal to SF-6D in Chinese patients with colorectal neoplasm. Value Health. 2012 May;15(3):495-503. doi: 10.1016/j.jval.2011.12.009. Epub 2012 Feb 17.
PubMed 22583460Wong CK, Lam CL, Mulhern B, Law WL, Poon JT, Kwong DL, Tsang J. Measurement invariance of the Functional Assessment of Cancer Therapy-Colorectal quality-of-life instrument among modes of administration. Qual Life Res. 2013 Aug;22(6):1415-26. doi: 10.1007/s11136-012-0272-x. Epub 2012 Sep 28.
PubMed 23054490Wong CK, Lam CL, Poon JT, Kwong DL. Clinical correlates of health preference and generic health-related quality of life in patients with colorectal neoplasms. PLoS One. 2013;8(3):e58341. doi: 10.1371/journal.pone.0058341. Epub 2013 Mar 13.
PubMed 23516465Wong CK, Lam CL, Law WL, Poon JT, Kwong DL, Tsang J, Wan YF. Condition-specific measure was more responsive than generic measure in colorectal cancer: all but social domains. J Clin Epidemiol. 2013 May;66(5):557-65. doi: 10.1016/j.jclinepi.2012.11.010. Epub 2013 Feb 8.
PubMed 23548135Wong CK, Lam CL, Wan YF, Rowen D. Predicting SF-6D from the European Organization for Treatment and Research of Cancer Quality of Life Questionnaire scores in patients with colorectal cancer. Value Health. 2013 Mar-Apr;16(2):373-84. doi: 10.1016/j.jval.2012.12.004.
PubMed 23538190Wong CK, Mulhern B, Wan YF, Lam CL. Responsiveness was similar between direct and mapped SF-6D in colorectal cancer patients who declined. J Clin Epidemiol. 2014 Feb;67(2):219-27. doi: 10.1016/j.jclinepi.2013.08.011. Epub 2013 Nov 1.
PubMed 24189090Wong CK, Law WL, Wan YF, Poon JT, Lam CL. Health-related quality of life and risk of colorectal cancer recurrence and All-cause death among advanced stages of colorectal cancer 1-year after diagnosis. BMC Cancer. 2014 May 17;14:337. doi: 10.1186/1471-2407-14-337.
PubMed 24886385Yang Y, Wong MY, Lam CL, Wong CK. Improving the mapping of condition-specific health-related quality of life onto SF-6D score. Qual Life Res. 2014 Oct;23(8):2343-53. doi: 10.1007/s11136-014-0668-x. Epub 2014 Mar 29.
PubMed 24682669Wong CK, Chen J, Yu CL, Sham M, Lam CL. Systematic review recommends the European Organization for Research and Treatment of Cancer colorectal cancer-specific module for measuring quality of life in colorectal cancer patients. J Clin Epidemiol. 2015 Mar;68(3):266-78. doi: 10.1016/j.jclinepi.2014.09.021. Epub 2014 Nov 6.
PubMed 25455838Lam CL, Law WL, Poon JT, Chan P, Wong CK, McGhee SM, Fong DY. Health-related quality of life in patients with colorectal neoplasm and cost-effectiveness of colorectal cancer screening in Hong Kong. Hong Kong Med J. 2015 Dec;21 Suppl 6:4-8. No abstract available.
PubMed 26645874Wong CK, Lam CL, Wan YF, Fong DY. Cost-effectiveness simulation and analysis of colorectal cancer screening in Hong Kong Chinese population: comparison amongst colonoscopy, guaiac and immunologic fecal occult blood testing. BMC Cancer. 2015 Oct 15;15:705. doi: 10.1186/s12885-015-1730-y.
PubMed 26471036
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Health-related Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening in Hong Kong
- ClinicalTrials.gov ID
- NCT02038283
- Acronym / sponsor ID
- HKCTR-973
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Early Detection of Cancer, Quality of Life, Quality-Adjusted Life Years, Direct Service Costs, Cost-Benefit Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Food and Health Bureau, Hong Kong
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong Kong and the second leading cause of cancer death in this population. Several screening strategies has been associated with improved survival and may affect patients' health-related quality of life (HRQOL). HRQOL impact should be used to adjust for survival in terms of quality adjusted life years (QALY) in the evaluation of cost-effectiveness of any intervention including screening.
Objectives: to determine the HRQOL and health preference of patients with different stages of colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for increasing QALYs.
Design and Subjects: A longitudinal survey to collect data on HRQOL associated with colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified sample of 420 patients with colorectal polyps and different stages of CRC will be recruited from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment. The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference data will be integrated with cost and effectiveness data obtained from the literature to determine the cost-effectiveness of currently recommended CRC screening strategies by Markov modeling.
Main outcome measures: The primary outcome measure is the SF-6D health preference value and QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared between patients with different stages of colorectal neoplasm. Markov modeling study will estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC screening strategy.
Results: The study will provide information on HRQOL of patients with colorectal neoplasm to guide health services. The Markov Model will identify the most cost-effective CRC screening strategy for Hong Kong Chinese, which can inform policy makers and the public for the prevention of CRC of the population.
Detailed description
The aims are to determine the HRQOL and health preference (utility) of different stages of colorectal neoplasm in order to evaluate the cost-effectiveness of different CRC screening strategies for the Chinese population in Hong Kong.
The specific objectives are:
- To determine the HRQOL preference values of patients in different stage of colorectal neoplasm in order to estimate the quality of life adjustment applicable to each stage of colorectal neoplasm.
- To evaluate the HRQOL of patients with colorectal neoplasm in order to find out their concerns and needs.
- To find out whether HRQOL preference of people with colorectal neoplasm changes with time.
- To determine the expected life years gained from the reduction in the incidence and mortality rates of CRC for each CRC screening strategy base on literature review.
- To determine the QALY gained from each CRC strategy by combining the preference value with life years gained.
- To identify the most cost-effective CRC screening strategy and to determine the incremental cost per additional QALY gained compared to no screening, by Markov modelling.
The study hypotheses are:
- Patients with colorectal neoplasm including those with polyps have lower HRQOL than the general population.
- There is a gradient reduction in HRQOL preference among patients with different stages colorectal neoplasm from polyp to metastatic cancer.
- HRQOL preference of patients with colorectal neoplasm is stable if there is no change in the disease stage.
- Annual I-FOBT is the most cost-effective CRC screening strategy for the Chinese population in Hong Kong.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low-risk Colorectal Polyps | – | –≤2 adenomas or 3-4 adenomas all of which are <1cm |
| High-risk Colorectal Polyps | – | –≥5 adenomas or ≥3 adenomas at least one of which is ≥1cm |
| Stage I CRC | – | –at least six months since diagnosis of Stage I CRC |
| Stage II CRC | – | –at least six months since diagnosis of Stage II CRC |
| Stage III CRC | – | –at least six months since diagnosis of Stage III CRC |
| Stage IV CRC | – | –at least six months since diagnosis of Stage IV CRC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Chinese patients of 18 years old or above with a histology of confirmed colorectal polyp or cancer for at least six months were recruited from specialist outpatient medical and surgical colorectal clinics of Queen Mary hospital in Hong Kong.
Key inclusion criteria (4 listed)
- Age 18 years or above
- Have life expectancy of at least 6 months
- Have confirmed diagnosis of any of the following colorectal neoplasm classified by the screening surveillance guideline and UICC/AJCC (TNM) staging system
- Have given consent to take part in the study
Key exclusion criteria (4 listed)
- Inability to understand or communicate in Cantonese or Chinese
- Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
- Too ill to carry out an interview
- Refuse to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SF-6D Preference-based Value
Time frame: Twelve months
HRQOL preference value measured by The Chinese (HK) SF-6D Health Survey was calculated by the HK population specific algorithm. It ranges from 0 (death) to 1 (perfect health).
Quality-adjusted life years for each screening strategy
Time frame: Baseline
The effectiveness of CRC screening is quantified by Quality-adjusted life years, which was calculated as the product of average duration of each health state (including no illness) and the SF-6D preference value for that particular health state.
Direct Health Care Costs for each CRC screening strategy
Time frame: Baseline
The direct health care costs of different CRC screening strategies and treatments of different stages of CRC were estimated using the costs published by the Government Gazette.
3 secondary outcomes
HRQOL by SF-12v2 and FACT-C
Time frame: Twelve months
Health Service Utilizations
Time frame: Baseline
Factors Associated with HRQOL
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Results publication: PubMed 21851512Wong CK, Lam CL, Law WL, Poon JT, Chan P, Kwong DL, Tsang J. Validity and reliability study on traditional Chinese FACT-C in Chinese patients with colorectal neoplasm. J Eval Clin Pract. 2012 Dec;18(6):1186-95. doi: 10.1111/j.1365-2753.2011.01753.x. Epub 2011 Aug 18.
- Results publication: PubMed 22111837Wong CK, Lam CL, Poon JT, McGhee SM, Law WL, Kwong DL, Tsang J, Chan P. Direct medical costs of care for Chinese patients with colorectal neoplasia: a health care service provider perspective. J Eval Clin Pract. 2012 Dec;18(6):1203-10. doi: 10.1111/j.1365-2753.2011.01776.x. Epub 2011 Nov 23.
- Results publication: PubMed 22583460Wong CK, Lam CL, Rowen D, McGhee SM, Ma KP, Law WL, Poon JT, Chan P, Kwong DL, Tsang J. Mapping the Functional Assessment of Cancer Therapy-general or -Colorectal to SF-6D in Chinese patients with colorectal neoplasm. Value Health. 2012 May;15(3):495-503. doi: 10.1016/j.jval.2011.12.009. Epub 2012 Feb 17.
- Results publication: PubMed 23054490Wong CK, Lam CL, Mulhern B, Law WL, Poon JT, Kwong DL, Tsang J. Measurement invariance of the Functional Assessment of Cancer Therapy-Colorectal quality-of-life instrument among modes of administration. Qual Life Res. 2013 Aug;22(6):1415-26. doi: 10.1007/s11136-012-0272-x. Epub 2012 Sep 28.
- Results publication: PubMed 23516465Wong CK, Lam CL, Poon JT, Kwong DL. Clinical correlates of health preference and generic health-related quality of life in patients with colorectal neoplasms. PLoS One. 2013;8(3):e58341. doi: 10.1371/journal.pone.0058341. Epub 2013 Mar 13.
- Results publication: PubMed 23548135Wong CK, Lam CL, Law WL, Poon JT, Kwong DL, Tsang J, Wan YF. Condition-specific measure was more responsive than generic measure in colorectal cancer: all but social domains. J Clin Epidemiol. 2013 May;66(5):557-65. doi: 10.1016/j.jclinepi.2012.11.010. Epub 2013 Feb 8.
- Results publication: PubMed 23538190Wong CK, Lam CL, Wan YF, Rowen D. Predicting SF-6D from the European Organization for Treatment and Research of Cancer Quality of Life Questionnaire scores in patients with colorectal cancer. Value Health. 2013 Mar-Apr;16(2):373-84. doi: 10.1016/j.jval.2012.12.004.
- Results publication: PubMed 24189090Wong CK, Mulhern B, Wan YF, Lam CL. Responsiveness was similar between direct and mapped SF-6D in colorectal cancer patients who declined. J Clin Epidemiol. 2014 Feb;67(2):219-27. doi: 10.1016/j.jclinepi.2013.08.011. Epub 2013 Nov 1.
- Results publication: PubMed 24886385Wong CK, Law WL, Wan YF, Poon JT, Lam CL. Health-related quality of life and risk of colorectal cancer recurrence and All-cause death among advanced stages of colorectal cancer 1-year after diagnosis. BMC Cancer. 2014 May 17;14:337. doi: 10.1186/1471-2407-14-337.
- Results publication: PubMed 24682669Yang Y, Wong MY, Lam CL, Wong CK. Improving the mapping of condition-specific health-related quality of life onto SF-6D score. Qual Life Res. 2014 Oct;23(8):2343-53. doi: 10.1007/s11136-014-0668-x. Epub 2014 Mar 29.
- Results publication: PubMed 25455838Wong CK, Chen J, Yu CL, Sham M, Lam CL. Systematic review recommends the European Organization for Research and Treatment of Cancer colorectal cancer-specific module for measuring quality of life in colorectal cancer patients. J Clin Epidemiol. 2015 Mar;68(3):266-78. doi: 10.1016/j.jclinepi.2014.09.021. Epub 2014 Nov 6.
- Results publication: PubMed 26645874Lam CL, Law WL, Poon JT, Chan P, Wong CK, McGhee SM, Fong DY. Health-related quality of life in patients with colorectal neoplasm and cost-effectiveness of colorectal cancer screening in Hong Kong. Hong Kong Med J. 2015 Dec;21 Suppl 6:4-8. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L.K. Lam, MD principal investigator
Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by The University of Hong Kong at 3 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-6D Preference-based Value (time frame: Twelve months). 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 NCT02038283, which also lists 13 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 16 May 2016.