Validation of Advanced Colorectal Neoplasm Risk Categories in a Prospective Cohort in Mexico

NCT05661292 | Unknown

• 1 other identifier: HEM-2756-18-21-1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Colorectal Cancer Screening

Keywords

Colorectal cancer; Screening; Mexico

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (2)

• Development and validation of a novel risk stratification model to detect Advanced Colorectal Neoplasia (ACN) in Mexican population.

  3 years

• Optimal Fecal Immunochemical Test (FIT) valued for Advanced Colorectal Neoplasia (ACN) detection.

  3 years

Interventions

Fecal inmunochemical test DIAGNOSTIC_TEST

A fecal inmunochemical test will be performed prior to colonoscopy.

Also known as: FIT

Colonoscopy DIAGNOSTIC_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 research BIOLOGICAL

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.

Also known as: Tissue, blood and urine

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Conquer Cancer Foundation: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

Related Publications (35)

• 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.

  PMID: 24672652 BACKGROUND

• Baxter 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.

  PMID: 22689809 BACKGROUND

• Brenner 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.

  PMID: 22826281 BACKGROUND

• Bujanda 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.

  PMID: 20593495 BACKGROUND

• Chiang 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.

  PMID: 25200099 BACKGROUND

• Coleman 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.

  PMID: 26082403 BACKGROUND

• Eduardo 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

• 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.

  PMID: 19114701 BACKGROUND

• Flitcroft 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.

  PMID: 23272939 BACKGROUND

• Fraser 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.

  PMID: 22472305 BACKGROUND

• Guy 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.

  PMID: 24737634 BACKGROUND

• Hernandez 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.

  PMID: 24574776 BACKGROUND

• Hol 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.

  PMID: 19671542 BACKGROUND

• Hol 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.

  PMID: 19337257 BACKGROUND

• Howlader 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.

  BACKGROUND

• Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.

  PMID: 24645800 BACKGROUND

• Inadomi JM. Screening for Colorectal Neoplasia. N Engl J Med. 2017 Apr 20;376(16):1599-1600. doi: 10.1056/NEJMc1702535. No abstract available.

  PMID: 28423294 BACKGROUND

• Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

  PMID: 21296855 BACKGROUND

• Jenkins PJ, Fairclough PD; British Society for Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Screening guidelines for colorectal cancer and polyps in patients with acromegaly. Gut. 2002 Oct;51 Suppl 5(Suppl 5):V13-4. doi: 10.1136/gut.51.suppl_5.v13. No abstract available.

  PMID: 12221033 BACKGROUND

• Langner C. Serrated and non-serrated precursor lesions of colorectal cancer. Dig Dis. 2015;33(1):28-37. doi: 10.1159/000366032. Epub 2014 Dec 17.

  PMID: 25531494 BACKGROUND

• Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.

  PMID: 24658694 BACKGROUND

• Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Lieberman N, Klang S, Niv Y. Sensitivity, but not specificity, of a quantitative immunochemical fecal occult blood test for neoplasia is slightly increased by the use of low-dose aspirin, NSAIDs, and anticoagulants. Am J Gastroenterol. 2009 Apr;104(4):933-8. doi: 10.1038/ajg.2009.14. Epub 2009 Mar 17.

  PMID: 19293792 BACKGROUND

• Muto T, Bussey HJ, Morson BC. The evolution of cancer of the colon and rectum. Cancer. 1975 Dec;36(6):2251-70. doi: 10.1002/cncr.2820360944.

  PMID: 1203876 BACKGROUND

• Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, Han DS. Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. Am J Gastroenterol. 2010 Sep;105(9):2017-25. doi: 10.1038/ajg.2010.179. Epub 2010 May 25.

  PMID: 20502450 BACKGROUND

• Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.

  PMID: 22356323 BACKGROUND

• Stegeman I, de Wijkerslooth TR, Stoop EM, van Leerdam M, van Ballegooijen M, Kraaijenhagen RA, Fockens P, Kuipers EJ, Dekker E, Bossuyt PM. Risk factors for false positive and for false negative test results in screening with fecal occult blood testing. Int J Cancer. 2013 Nov 15;133(10):2408-14. doi: 10.1002/ijc.28242. Epub 2013 Jun 25.

  PMID: 23649826 BACKGROUND

• van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, Verbeek AL, Jansen JB, Dekker E. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology. 2008 Jul;135(1):82-90. doi: 10.1053/j.gastro.2008.03.040. Epub 2008 Mar 25.

  PMID: 18482589 BACKGROUND

• van Turenhout ST, Oort FA, Terhaar sive Droste JS, Coupe VM, van der Hulst RW, Loffeld RJ, Scholten P, Depla AC, Bouman AA, Meijer GA, Mulder CJ, van Rossum LG. Hemorrhoids detected at colonoscopy: an infrequent cause of false-positive fecal immunochemical test results. Gastrointest Endosc. 2012 Jul;76(1):136-43. doi: 10.1016/j.gie.2012.03.169.

  PMID: 22726472 BACKGROUND

• Williams JG, Pullan RD, Hill J, Horgan PG, Salmo E, Buchanan GN, Rasheed S, McGee SG, Haboubi N; Association of Coloproctology of Great Britain and Ireland. Management of the malignant colorectal polyp: ACPGBI position statement. Colorectal Dis. 2013 Aug;15 Suppl 2:1-38. doi: 10.1111/codi.12262. No abstract available.

  PMID: 23848492 BACKGROUND

• Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.

  PMID: 8247072 BACKGROUND

• Wong MC, Ching JY, Chan VC, Lam TY, Luk AK, Ng SS, Sung JJ. Factors associated with false-positive and false-negative fecal immunochemical test results for colorectal cancer screening. Gastrointest Endosc. 2015 Mar;81(3):596-607. doi: 10.1016/j.gie.2014.08.006. Epub 2014 Oct 5.

  PMID: 25293827 BACKGROUND

• Yeoh KG, Ho KY, Chiu HM, Zhu F, Ching JY, Wu DC, Matsuda T, Byeon JS, Lee SK, Goh KL, Sollano J, Rerknimitr R, Leong R, Tsoi K, Lin JT, Sung JJ; Asia-Pacific Working Group on Colorectal Cancer. The Asia-Pacific Colorectal Screening score: a validated tool that stratifies risk for colorectal advanced neoplasia in asymptomatic Asian subjects. Gut. 2011 Sep;60(9):1236-41. doi: 10.1136/gut.2010.221168. Epub 2011 Mar 14.

  PMID: 21402615 BACKGROUND

• Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10.

  PMID: 25492500 BACKGROUND

• Zauber AG. The impact of screening on colorectal cancer mortality and incidence: has it really made a difference? Dig Dis Sci. 2015 Mar;60(3):681-91. doi: 10.1007/s10620-015-3600-5. Epub 2015 Mar 5.

  PMID: 25740556 BACKGROUND

• Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.

  PMID: 22356322 BACKGROUND

Related Links

• GLOBOCAN
• Population pyramid

Biospecimen

Retention: SAMPLES WITH DNA

This is an optional research. If the subject accept to participate, we will get and store: 1. Blood: 15 ml 2. Urine: 20 ml 3. Tissue samples: just when biopsies were taken in the colonoscopy for diagnostic purposes. No additional biopsies not required for medical attention will be taken. These tissue samples will be used just when they are not required to stablish a diagnosis. All these samples will be storage and used for future biomedical research.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Blood Specimen Collection; Urination; Histocompatibility Testing

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Immunologic Tests; Immunologic Techniques

Study Officials

• Fidel D Huitzil-Melendez, MS

  Instituto Nacional de Ciencias Médicas y Nutrición

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fidel D Huitzil-Melendez, MS

CONTACT

5254870900; drdavidhuitzil@gmail.com

Mónica I Meneses-Medina, MD

CONTACT

5254870900; mimm2404@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: December 22, 2022
• Study Start: August 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)