Colorectal Cancer ScreeningCOLOFITNCT05661292
Validation of Advanced Colorectal Neoplasm Risk Categories in a Prospective Cohort in Mexico
An observational study of Colorectal Cancer Screening, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Worldwide, there are 1,361,000 new cases of colorectal cancers (CRC) annually, with 694,000 deaths. However, the incidence varies by up to a factor of 10x between high and low incidence countries (eg. USA vs Mexico, incidence rate of 42.54 vs 7.44 / 100,000 inhabitants). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Fecal inmunochemical test, Colonoscopy and Optional collection of tissue, blood and urine for future biomedical research
- How many people
- 2,000 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2019to 30 Mar 2025
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects eligible for CRC screening with or without institutional registry. Subjects with institutional registry will be identified among patients treated at the Internal Medicine clinic of the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" in Mexico City. Patients without institutional registry will be identified among relatives of participants, blood bank, and by diffusion of the protocol with leaflets on social networks and internal at our center.
Who may be able to join
- Asymptomatic subjects between 50 and 75 years of age-eligible for CRC screening with or without registry at the institute.
- Note: concerning symptoms of CRC diagnosis will not be admitted: fresh blood in the stool, black stools, unexplained weight loss (>10% of usual body weight). Concerning symptoms of Functional Gastrointestinal Disorder (FGID) will be permitted: loss of appetite, diarrhea, constipation, abdominal pain or discomfort.
- Subjects who give their informed consent.
- Subjects who have completed the vaccination schedule against the SARS CoV-2 virus with any of the vaccines approved in Mexico, at least 4 weeks before the colonoscopy.
Who cannot join
- Personal history of any type of cancer, except basal cell carcinoma or cervical cancer in situ.
- Personal history of colon polyps.
- Personal history of abdominal or pelvic radiation due to previous cancer.
- Relatives with familial adenomatous polyposis (FAP) or hereditary non-polyposis CRC.
- Inflammatory bowel disease (IBD).
- High anesthetic risk (ASA greater than 3 of the classification of the American Society of Anesthesiology).
Show all 15Show fewer
- Any medical condition that limits life expectancy at the discretion of the investigator.
- Charlson index > 4.
- Presence of anemia in the last year according to the WHO definition: women <12 g/dl, men <13 g/dl.
- Previous colectomy.
- Colonoscopy in the previous 5 years.
- Sigmoidoscopy in the previous 3 years.
- A fecal occult blood test in the past year.
- CT colonography in the previous 10 years.
- Clinical data suggestive of CRC such as hematochezia, melena, weight loss greater than 10% of usual body weight in a 6 months period.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
Mónica I Meneses Medina, MD, 54870900 ext. 2254, mimm2404@hotmail.com
Vanessa Rosas Camargo, MD, 54870900 ext. 2254, dravanessarosascamargo@yahoo.com.mx
About this study
Official title: Validation of Advanced Colorectal Neoplasm Risk Categories in Screening Colonoscopy and Identification of Biomarkers in a Prospective Cohort in Mexico.
Worldwide, there are 1,361,000 new cases of colorectal cancers (CRC) annually, with 694,000 deaths. However, the incidence varies by up to a factor of 10x between high and low incidence countries (eg. USA vs Mexico, incidence rate of 42.54 vs 7.44 / 100,000 inhabitants). Mexico is considered a low-incidence country, with 8,651 new cases and 4,694 deaths annually.
CRC is a preventable and detectable disease. Screening programs established in high-incidence countries have managed to reduce the incidence and mortality from this disease and it is considered a cost-effective strategy. In less developed countries where there are no screening programs for CRC, the highest number of deaths occurs despite having the lowest number of cases. It is recognized that a barrier to establishing a screening program in a country with low incidence and limited resources is cost-effectiveness.
Read more
The prevalence of Advanced Colorectal Neoplasia (ACN) detected by screening colonoscopy in a Mexican cohort of 1172 INNSZ patients was 2.9%. In the US the prevalence is 7.6%. The number of colonoscopies to be performed to detect ACN was estimated at 34 for Mexico and 13 for the US, which suggests that the cost-effectiveness of screening colonoscopy could be 3 times lower in our country.
In Mexico there is no national screening program for CRC. The eligible population (adults between 50 and 75 years old) for CRC screening is estimated in 20 million of Mexicans. It is recognized that Mexico does not have enough financial resources nor the infrastructure to screen the entire eligible population either by direct colonoscopy, or by FIT (fecal immunochemical test) followed by colonoscopy. With a 5% frequency of positive FIT, nearly 1,000,000 follow-up colonoscopies would be required annually in a population screening program.
An alternative could be to offer screening based on risk, which means only offering screening to the highest-risk population.
There are calculators to predict the risk of identifying ACN in a screening colonoscopy, however, none have been developed and validated in the Mexican population. The weight of the risk factors associated with ACN in the Mexican population could be different, so it is necessary to develop and validate an ACN risk calculator that allows the Mexican population to be stratified and to concentrate screening efforts on the population at highest risk.
Read the detailed description
This is a prospective cohort of subjects eligible for CRC screening in Mexico City.
The main goal is to validate the APCS clinical score as a risk - stratification tool for screening colonoscopy in a Mexican population.
The Asian-Pacific Colorectal Screening (APCS) score is a clinical tool used to stratify subjects according to the probability of identification of Advanced Colorectal Neoplasia (ACN) in a screening colonoscopy. ACN includes lesions larger than 10 mm with one or more of the following: a villous content, high-grade dysplasia, or carcinoma. The tool stratifies the population into three risk categories, considering: age, sex, smoking history, and first-degree family history of colorectal cancer. The total score obtained allows the stratification into average risk (0-1 point), moderate (2-3 points), and high risk (4-7 points). The prevalence of ACN in the original validation cohort of the APCS was 1.3% for average risk, 3.2% in moderate risk and 5.2% in high risk.
Investigators previously evaluated the APCS score in a retrospective study of screening colonoscopy in Mexican population (n=1269). The prevalence of ACN was 2.6% vs 5.2% (p=0.027) for moderate risk and high-risk categories, respectively.
To implement a risk-stratified screening program for the Mexican population, prospective validation was considered necessary. A prospective study would allow for collection and evaluation of additional variables that could potentially improve APCS score. FIT cut-off values have never been validated in Mexican population and are required to implement a national colorectal screening program. Prospective design will also allow for bio banking for future medical research.
The following procedures will be performed:
- Subjects will be invited to participate in the study, and if they accept, an informed consent will be given and explained to them. They will have a standardized interview dedicated to promoting CRC screening and complete a CRC risk factor questionnaire to determine their risk category.
- Subjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis.
- A Fecal Immunochemical Test (FIT) will be performed prior to the colonoscopy. Note: A positive FIT will have a Hb value >20 ug/g of stool.
- A colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and physician will be blinded to FIT test results and risk category. In subsequent medical consultation, the results of the risk score, the FIT test, and colonoscopy will be discussed.
- If the patient does not perform any of the tests, they will be interviewed on a second occasion to complete a questionnaire of reasons of rejection. NOTE: It is anticipated that a proportion of subjects will verbally accept the screening, but the proposed tests will not be carried out (this will measure the percentage of acceptance of the recommendation).
Given that age and gender are the most important risk factors, the population will be stratified simulating the Mexican population pyramid as follows: 50% male subjects and 50% female subjects. By age groups: 50-54 years (31%), 55-59 (24%), 60-64 (19%), 65-69 (14%), 70-75 (12%).
The data collected from the participants will be entered into an electronic registry (Redcap) in real-time. A periodic review of the electronic registry will be carried out by personal of the protocol to ensure the quality of the information and that it is complete. The study does not contemplate external monitoring of the data.
Statistical considerations
- Sample size: for a difference in proportions of 2.6% (prevalence of ACN 5.2% vs. 2.6% in the high vs. moderate-risk population), 868 subjects per group are required to achieve a power of 80%, with a confidence level of 95 %, that is, 1736 subjects. It is anticipated that in 15% of the subjects the two screening tests will not be available, so a total sample of 2000 subjects is proposed.
- Statistical proportions, means, and medians will be used to describe the population. The differences in proportions will be analyzed with the X2 test. Using a binary logistic regression model, variables associated with ACN risk will be identified. A p < 0.05 will be considered statistically significant. The risk calculator will be developed using the variables identified in the univariate analysis and differential weight will be assigned to them according to risk. To determine the optimal cut-off point in FIT test (ng of hemoglobin per gram of feces): the investigators will use the distribution of the FIT score for patients with and without premalignant lesions and/or colorectal cancer to estimate sensitivity and specificity. according to different cut-off values. Subsequently, the investigators will use a decision model based on specificity/sensitivity ROC curves and according to different FIT cut-off points. The closer the ROC curve is to the upper left corner, the higher the predictive power of detecting colorectal lesions.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Fecal inmunochemical test, Colonoscopy, Optional collection of tissue, blood and urine for future biomedical research
- Keywords
- Colorectal cancer, Screening, Mexico
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal inmunochemical testDiagnostic test
Also called FIT
A fecal inmunochemical test will be performed prior to colonoscopy.
ColonoscopyDiagnostic test
A colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and colonoscopist will be blinded to FIT test results and risk category.
Optional collection of tissue, blood and urine for future biomedical researchBiological
Also called Tissue, blood and urine
Subjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Asian Pacific Colorectal Screening (APCS) score validation in Mexican population.
Estimation of the prevalence of Advanced colorectal neoplasia (ACN) in high-risk category compared to the prevalence of ACN in moderate-risk category according to APCS score in screening colonoscopy. The tool stratifies the population into three risk categories, taking into account: age, sex, smoking history, and first-degree family history of colorectal cancer. The total score obtained allows the stratification into average risk (0-1 point), moderate (2-3 points), and high risk (4-7 points) categories. The prevalence of ACN in the original validation cohort of the APCS was 1.3% for average risk, 3.2% in moderate risk and 5.2% in high risk categories.
Measured: 3 years
Secondary outcomes (2)
Development and validation of a novel risk stratification model to detect Advanced Colorectal Neoplasia (ACN) in Mexican population.
Risk ratio (RR) of variables relevant to Mexican population related to ACN will be identified in prospectively collected clinical questionnaires.
The variables include:
demographic data (sex and age), familiar history, presence of diabetes and hypertension, body mass index, smoking history, Non-Steroideal Anti-Inflammatory Drugs (NSAIDs) consumption, diet and physical activity. Selected variables will be incorporated in a new model to have two risk groups, a high and a low risk. Each group defines the risk of find ACN in a screening colonoscopy. The performance of the new model will be evaluated by comparing the RR of ACN in high vs low risk categories.
Measured: 3 years
Optimal Fecal Immunochemical Test (FIT) valued for Advanced Colorectal Neoplasia (ACN) detection.
Hemoglobin per gram of feces to categorize a FIT as positive for ACN detection derived from a Receiver Operating Characteristic (ROC) curve analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Aug 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Responsible party
- Principal investigator, David Huitzil m, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Fidel D Huitzil-Melendez, MS, Principal investigator, Instituto Nacional de Ciencias Médicas y Nutrición
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661292
- Sponsor's protocol ID
- HEM-2756-18-21-1
- Acronym
- COLOFIT
- Status last verified
- Jan 2023
- First submitted
- 4 Mar 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not aplicable
Publications
Allison JE, Fraser CG, Halloran SP, Young GP. Population screening for colorectal cancer means getting FIT: the past, present, and future of colorectal cancer screening using the fecal immunochemical test for hemoglobin (FIT). Gut Liver. 2014 Mar;8(2):117-30. doi: 10.5009/gnl.2014.8.2.117. Epub 2014 Mar 11.
PubMed 24672652Baxter NN, Warren JL, Barrett MJ, Stukel TA, Doria-Rose VP. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol. 2012 Jul 20;30(21):2664-9. doi: 10.1200/JCO.2011.40.4772. Epub 2012 Jun 11.
PubMed 22689809Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
PubMed 22826281Bujanda L, Cosme A, Gil I, Arenas-Mirave JI. Malignant colorectal polyps. World J Gastroenterol. 2010 Jul 7;16(25):3103-11. doi: 10.3748/wjg.v16.i25.3103.
PubMed 20593495Chiang TH, Chuang SL, Chen SL, Chiu HM, Yen AM, Chiu SY, Fann JC, Chou CK, Lee YC, Wu MS, Chen HH. Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program. Gastroenterology. 2014 Dec;147(6):1317-26. doi: 10.1053/j.gastro.2014.08.043. Epub 2014 Sep 6.
PubMed 25200099Coleman HG, Loughrey MB, Murray LJ, Johnston BT, Gavin AT, Shrubsole MJ, Bhat SK, Allen PB, McConnell V, Cantwell MM. Colorectal Cancer Risk Following Adenoma Removal: A Large Prospective Population-Based Cohort Study. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1373-80. doi: 10.1158/1055-9965.EPI-15-0085. Epub 2015 Jun 16.
PubMed 26082403Eduardo Negrete Carballo, Fidel David Huitzil Melendez. Prevalence of advanced colorectal neoplasia according to risk categories at screening colonoscopy in a tertiary referral center. Journal of Clinical Oncology 36, no. 4_suppl (February 2018) 578-578. DOI: 10.1200/JCO.2018.36.4_suppl.578.
Freedman AN, Slattery ML, Ballard-Barbash R, Willis G, Cann BJ, Pee D, Gail MH, Pfeiffer RM. Colorectal cancer risk prediction tool for white men and women without known susceptibility. J Clin Oncol. 2009 Feb 10;27(5):686-93. doi: 10.1200/JCO.2008.17.4797. Epub 2008 Dec 29.
PubMed 19114701Flitcroft KL, Irwig LM, Carter SM, Salkeld GP, Gillespie JA. Colorectal cancer screening: why immunochemical fecal occult blood tests may be the best option. BMC Gastroenterol. 2012 Dec 29;12:183. doi: 10.1186/1471-230X-12-183.
PubMed 23272939Fraser CG, Allison JE, Halloran SP, Young GP; Expert Working Group on Fecal Immunochemical Tests for Hemoglobin, Colorectal Cancer Screening Committee, World Endoscopy Organization. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst. 2012 Jun 6;104(11):810-4. doi: 10.1093/jnci/djs190. Epub 2012 Apr 2.
PubMed 22472305Guy GP Jr, Richardson LC, Pignone MP, Plescia M. Costs and benefits of an organized fecal immunochemical test-based colorectal cancer screening program in the United States. Cancer. 2014 Aug 1;120(15):2308-15. doi: 10.1002/cncr.28724. Epub 2014 Apr 15.
PubMed 24737634Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038.
PubMed 24574776Hol L, van Leerdam ME, van Ballegooijen M, van Vuuren AJ, van Dekken H, Reijerink JC, van der Togt AC, Habbema JD, Kuipers EJ. Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut. 2010 Jan;59(1):62-8. doi: 10.1136/gut.2009.177089.
PubMed 19671542Hol L, Wilschut JA, van Ballegooijen M, van Vuuren AJ, van der Valk H, Reijerink JC, van der Togt AC, Kuipers EJ, Habbema JD, van Leerdam ME. Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. Br J Cancer. 2009 Apr 7;100(7):1103-10. doi: 10.1038/sj.bjc.6604961.
PubMed 19337257Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2011. Bethesda MD: National Cancer Institute; 2014. http://seer.cancer.gov./csr/1975_2011/, based on November 2013 SEER data submission, posted to the SEER web site.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Advanced Colorectal Neoplasm Risk Categories in Screening Colonoscopy and Identification of Biomarkers in a Prospective Cohort in Mexico.
- ClinicalTrials.gov ID
- NCT05661292
- Acronym / sponsor ID
- COLOFIT / HEM-2756-18-21-1
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal cancer, Screening, Mexico
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 22 Dec 2022 (actual)
- 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.
Worldwide, there are 1,361,000 new cases of colorectal cancers (CRC) annually, with 694,000 deaths. However, the incidence varies by up to a factor of 10x between high and low incidence countries (eg. USA vs Mexico, incidence rate of 42.54 vs 7.44 / 100,000 inhabitants). Mexico is considered a low-incidence country, with 8,651 new cases and 4,694 deaths annually.
CRC is a preventable and detectable disease. Screening programs established in high-incidence countries have managed to reduce the incidence and mortality from this disease and it is considered a cost-effective strategy. In less developed countries where there are no screening programs for CRC, the highest number of deaths occurs despite having the lowest number of cases. It is recognized that a barrier to establishing a screening program in a country with low incidence and limited resources is cost-effectiveness.
The prevalence of Advanced Colorectal Neoplasia (ACN) detected by screening colonoscopy in a Mexican cohort of 1172 INNSZ patients was 2.9%. In the US the prevalence is 7.6%. The number of colonoscopies to be performed to detect ACN was estimated at 34 for Mexico and 13 for the US, which suggests that the cost-effectiveness of screening colonoscopy could be 3 times lower in our country.
In Mexico there is no national screening program for CRC. The eligible population (adults between 50 and 75 years old) for CRC screening is estimated in 20 million of Mexicans. It is recognized that Mexico does not have enough financial resources nor the infrastructure to screen the entire eligible population either by direct colonoscopy, or by FIT (fecal immunochemical test) followed by colonoscopy. With a 5% frequency of positive FIT, nearly 1,000,000 follow-up colonoscopies would be required annually in a population screening program.
An alternative could be to offer screening based on risk, which means only offering screening to the highest-risk population.
There are calculators to predict the risk of identifying ACN in a screening colonoscopy, however, none have been developed and validated in the Mexican population. The weight of the risk factors associated with ACN in the Mexican population could be different, so it is necessary to develop and validate an ACN risk calculator that allows the Mexican population to be stratified and to concentrate screening efforts on the population at highest risk.
Detailed description
This is a prospective cohort of subjects eligible for CRC screening in Mexico City.
The main goal is to validate the APCS clinical score as a risk - stratification tool for screening colonoscopy in a Mexican population.
The Asian-Pacific Colorectal Screening (APCS) score is a clinical tool used to stratify subjects according to the probability of identification of Advanced Colorectal Neoplasia (ACN) in a screening colonoscopy. ACN includes lesions larger than 10 mm with one or more of the following: a villous content, high-grade dysplasia, or carcinoma. The tool stratifies the population into three risk categories, considering: age, sex, smoking history, and first-degree family history of colorectal cancer. The total score obtained allows the stratification into average risk (0-1 point), moderate (2-3 points), and high risk (4-7 points). The prevalence of ACN in the original validation cohort of the APCS was 1.3% for average risk, 3.2% in moderate risk and 5.2% in high risk.
Investigators previously evaluated the APCS score in a retrospective study of screening colonoscopy in Mexican population (n=1269). The prevalence of ACN was 2.6% vs 5.2% (p=0.027) for moderate risk and high-risk categories, respectively.
To implement a risk-stratified screening program for the Mexican population, prospective validation was considered necessary. A prospective study would allow for collection and evaluation of additional variables that could potentially improve APCS score. FIT cut-off values have never been validated in Mexican population and are required to implement a national colorectal screening program. Prospective design will also allow for bio banking for future medical research.
The following procedures will be performed:
- Subjects will be invited to participate in the study, and if they accept, an informed consent will be given and explained to them. They will have a standardized interview dedicated to promoting CRC screening and complete a CRC risk factor questionnaire to determine their risk category.
- Subjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis.
- A Fecal Immunochemical Test (FIT) will be performed prior to the colonoscopy. Note: A positive FIT will have a Hb value >20 ug/g of stool.
- A colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and physician will be blinded to FIT test results and risk category. In subsequent medical consultation, the results of the risk score, the FIT test, and colonoscopy will be discussed.
- If the patient does not perform any of the tests, they will be interviewed on a second occasion to complete a questionnaire of reasons of rejection. NOTE: It is anticipated that a proportion of subjects will verbally accept the screening, but the proposed tests will not be carried out (this will measure the percentage of acceptance of the recommendation).
Given that age and gender are the most important risk factors, the population will be stratified simulating the Mexican population pyramid as follows: 50% male subjects and 50% female subjects. By age groups: 50-54 years (31%), 55-59 (24%), 60-64 (19%), 65-69 (14%), 70-75 (12%).
The data collected from the participants will be entered into an electronic registry (Redcap) in real-time. A periodic review of the electronic registry will be carried out by personal of the protocol to ensure the quality of the information and that it is complete. The study does not contemplate external monitoring of the data.
Statistical considerations
- Sample size: for a difference in proportions of 2.6% (prevalence of ACN 5.2% vs. 2.6% in the high vs. moderate-risk population), 868 subjects per group are required to achieve a power of 80%, with a confidence level of 95 %, that is, 1736 subjects. It is anticipated that in 15% of the subjects the two screening tests will not be available, so a total sample of 2000 subjects is proposed.
- Statistical proportions, means, and medians will be used to describe the population. The differences in proportions will be analyzed with the X2 test. Using a binary logistic regression model, variables associated with ACN risk will be identified. A p < 0.05 will be considered statistically significant. The risk calculator will be developed using the variables identified in the univariate analysis and differential weight will be assigned to them according to risk. To determine the optimal cut-off point in FIT test (ng of hemoglobin per gram of feces): the investigators will use the distribution of the FIT score for patients with and without premalignant lesions and/or colorectal cancer to estimate sensitivity and specificity. according to different cut-off values. Subsequently, the investigators will use a decision model based on specificity/sensitivity ROC curves and according to different FIT cut-off points. The closer the ROC curve is to the upper left corner, the higher the predictive power of detecting colorectal lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects eligible for CRC screening with or without institutional registry. Subjects with institutional registry will be identified among patients treated at the Internal Medicine clinic of the Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" in Mexico City. Patients without institutional registry will be identified among relatives of participants, blood bank, and by diffusion of the protocol with leaflets on social networks and internal at our center.
Key inclusion criteria (4 listed)
- Asymptomatic subjects between 50 and 75 years of age-eligible for CRC screening with or without registry at the institute.
- Note: concerning symptoms of CRC diagnosis will not be admitted: fresh blood in the stool, black stools, unexplained weight loss (>10% of usual body weight). Concerning symptoms of Functional Gastrointestinal Disorder (FGID) will be permitted: loss of appetite, diarrhea, constipation, abdominal pain or discomfort.
- Subjects who give their informed consent.
- Subjects who have completed the vaccination schedule against the SARS CoV-2 virus with any of the vaccines approved in Mexico, at least 4 weeks before the colonoscopy.
Key exclusion criteria (15 listed)
- Personal history of any type of cancer, except basal cell carcinoma or cervical cancer in situ.
- Personal history of colon polyps.
- Personal history of abdominal or pelvic radiation due to previous cancer.
- Relatives with familial adenomatous polyposis (FAP) or hereditary non-polyposis CRC.
- Inflammatory bowel disease (IBD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal inmunochemical testAlso: FITA fecal inmunochemical test will be performed prior to colonoscopy. | Diagnostic test | – |
| ColonoscopyA colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and colonoscopist will be blinded to FIT test results and risk category. | Diagnostic test | – |
| Optional collection of tissue, blood and urine for future biomedical researchAlso: Tissue, blood and urineSubjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis. | Biological | – |
Primary outcome
Asian Pacific Colorectal Screening (APCS) score validation in Mexican population.
Time frame: 3 years
Estimation of the prevalence of Advanced colorectal neoplasia (ACN) in high-risk category compared to the prevalence of ACN in moderate-risk category according to APCS score in screening colonoscopy. The tool stratifies the population into three risk categories, taking into account: age, sex, smoking history, and first-degree family history of colorectal cancer. The total score obtained allows the stratification into average risk (0-1 point), moderate (2-3 points), and high risk (4-7 points) categories. The prevalence of ACN in the original validation cohort of the APCS was 1.3% for average risk, 3.2% in moderate risk and 5.2% in high risk categories.
2 secondary outcomes
Development and validation of a novel risk stratification model to detect Advanced Colorectal Neoplasia (ACN) in Mexican population.
Time frame: 3 years
Optimal Fecal Immunochemical Test (FIT) valued for Advanced Colorectal Neoplasia (ACN) detection.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 24672652Allison JE, Fraser CG, Halloran SP, Young GP. Population screening for colorectal cancer means getting FIT: the past, present, and future of colorectal cancer screening using the fecal immunochemical test for hemoglobin (FIT). Gut Liver. 2014 Mar;8(2):117-30. doi: 10.5009/gnl.2014.8.2.117. Epub 2014 Mar 11.
- Background: PubMed 22689809Baxter NN, Warren JL, Barrett MJ, Stukel TA, Doria-Rose VP. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol. 2012 Jul 20;30(21):2664-9. doi: 10.1200/JCO.2011.40.4772. Epub 2012 Jun 11.
- Background: PubMed 22826281Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
- Background: PubMed 20593495Bujanda L, Cosme A, Gil I, Arenas-Mirave JI. Malignant colorectal polyps. World J Gastroenterol. 2010 Jul 7;16(25):3103-11. doi: 10.3748/wjg.v16.i25.3103.
- Background: PubMed 25200099Chiang TH, Chuang SL, Chen SL, Chiu HM, Yen AM, Chiu SY, Fann JC, Chou CK, Lee YC, Wu MS, Chen HH. Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program. Gastroenterology. 2014 Dec;147(6):1317-26. doi: 10.1053/j.gastro.2014.08.043. Epub 2014 Sep 6.
- Background: PubMed 26082403Coleman HG, Loughrey MB, Murray LJ, Johnston BT, Gavin AT, Shrubsole MJ, Bhat SK, Allen PB, McConnell V, Cantwell MM. Colorectal Cancer Risk Following Adenoma Removal: A Large Prospective Population-Based Cohort Study. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1373-80. doi: 10.1158/1055-9965.EPI-15-0085. Epub 2015 Jun 16.
- BackgroundEduardo Negrete Carballo, Fidel David Huitzil Melendez. Prevalence of advanced colorectal neoplasia according to risk categories at screening colonoscopy in a tertiary referral center. Journal of Clinical Oncology 36, no. 4_suppl (February 2018) 578-578. DOI: 10.1200/JCO.2018.36.4_suppl.578.
- Background: PubMed 19114701Freedman AN, Slattery ML, Ballard-Barbash R, Willis G, Cann BJ, Pee D, Gail MH, Pfeiffer RM. Colorectal cancer risk prediction tool for white men and women without known susceptibility. J Clin Oncol. 2009 Feb 10;27(5):686-93. doi: 10.1200/JCO.2008.17.4797. Epub 2008 Dec 29.
- Background: PubMed 23272939Flitcroft KL, Irwig LM, Carter SM, Salkeld GP, Gillespie JA. Colorectal cancer screening: why immunochemical fecal occult blood tests may be the best option. BMC Gastroenterol. 2012 Dec 29;12:183. doi: 10.1186/1471-230X-12-183.
- Background: PubMed 22472305Fraser CG, Allison JE, Halloran SP, Young GP; Expert Working Group on Fecal Immunochemical Tests for Hemoglobin, Colorectal Cancer Screening Committee, World Endoscopy Organization. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst. 2012 Jun 6;104(11):810-4. doi: 10.1093/jnci/djs190. Epub 2012 Apr 2.
- Background: PubMed 24737634Guy GP Jr, Richardson LC, Pignone MP, Plescia M. Costs and benefits of an organized fecal immunochemical test-based colorectal cancer screening program in the United States. Cancer. 2014 Aug 1;120(15):2308-15. doi: 10.1002/cncr.28724. Epub 2014 Apr 15.
- Background: PubMed 24574776Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038.
- GLOBOCANLink provided by the sponsor.
- Population pyramidLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not aplicable
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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.
Fidel D Huitzil-Melendez, MS principal investigator
Instituto Nacional de Ciencias Médicas y Nutrición
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Screening, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 15 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 26 Jan 2023. 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 Mexico. 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 Fidel D Huitzil-Melendez, MS (5254870900 ext. 2254, drdavidhuitzil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asian Pacific Colorectal Screening (APCS) score validation in Mexican population. (time frame: 3 years). 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 NCT05661292, which also lists 35 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 26 Jan 2023.