Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

NCT04967183 | Recruiting DMC

• 1 other identifier: POLYPREV
• Study Type: interventional
• Target: 3,788
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesions is detected, it is recommended to perform endoscopic surveillance with different intervals between explorations. Although the reduction in CRC incidence, endoscopic surveillance is producing a considerable increase in the number of colonoscopies. However, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non inferior alternative to endoscopic surveillance. Based on this hypothesis, the research group have designed a randomized clinical trial within the population CRC screening programs to compare FIT surveillance to endoscopic surveillance in patients with advanced lesions resected.

Conditions

Colorectal Cancer

Keywords

Screening program; Endoscopic surveillance; Fecal immunochemical test; Mediterranean diet; Physical activity

Outcome Measures

Primary Outcomes (6)

• Rate of invasive CRC

  It is the main outcome of the study. Invasive CRC is defined as colonic adenocarcinoma that invades the submucosa. Adenocarcinomas in situ and intramucosal carcinomas will not be considered as invasive CRC.

  10 years

• Rate of interval CRC

  Interval CRC is defined as the CRC detected between two organized surveillance (FIT or colonoscopy).

  10 years

• Mortality

  The deaths and their cause will be collected: associated with CRC, associated with adverse effects of screening or unrelated.

  10 years

• Rate of advanced colonic lesions

  Advanced colonic lesions will be defined as advanced adenomas (at least 10mm, hairy histology or high grade dysplasia) or advanced serrated lesions (at least 10mm or with dysplasia).

  10 years

• Frequency of participation in the surveillance strategy

  According to the methodology of the information systems of the screening programs, three categories will be defined: non-participation, irregular participation, regular participation.

  10 years

• Adverse effects

  Adverse effects associated with surveillance are defined as complications that require hospitalization. Those related to the surgical treatment of benign colonic lesions will be included as adverse effects.

  10 years

Secondary Outcomes (4)

• CRC, adenoma and advanced serrated lesions at three years

  3 years

• Physical activity

  3 years

• Mediterranean lifestyle

  3 years

• Preferences of the subjects

  2 years

Study Arms (2)

Group I

EXPERIMENTAL

Annual FIT surveillance

Diagnostic Test: Annual FIT

Group II

ACTIVE COMPARATOR

Endoscopic surveillance

Procedure: Endoscopic surveillance.

Interventions

Annual FIT DIAGNOSTIC_TEST

Patients will be offered an annual FIT and colonoscopy will be performed if fecal hemoglobin concentration is ≥10µg / g of feces. After performing a colonoscopy the FIT will be sent to the patient: * After one year if the unscheduled colonoscopy has been incomplete or a lesion requiring endoscopic surveillance has been completely resected. * After five years if the colonoscopy has evaluated the entire mucosa, it is normal or with lesions that do not require endoscopic surveillance (1-2 non-advanced adenomas).

Group I

Endoscopic surveillance. PROCEDURE

First surveillance colonoscopy will be performed in three-year time. If an advanced adenoma or at least three non-advanced adenomas are detected, colonoscopy will be repeated after 3 years. In contrast, if colonoscopy is normal or 1-2 non-advanced adenomas are detected, colonoscopy will be repeated after 5 years.

Group II

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 50 to 65 years.
• Individuals with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program.

You may not qualify if:

• Personal history of CRC.
• Colonic lesion ≥10mm resected without histological diagnosis.
• More than 10 adenomas in baseline colonoscopy.
• Serrated polyposis syndrome.
• Two or more first-degree relatives with CRC.
• Hereditary predisposition to CRC.
• Relevant comorbidity with life expectancy inferior to 5 years.
• Colonoscopy with incomplete mucosal examination.
• Incomplete resection of baseline lesions.
• Non-acceptance after reading the informed consent.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Complexo Hospitalario Universitario de Ourense

Ourense, 32002, Spain

RECRUITING

Related Publications (16)

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• Martinez ME, Baron JA, Lieberman DA, Schatzkin A, Lanza E, Winawer SJ, Zauber AG, Jiang R, Ahnen DJ, Bond JH, Church TR, Robertson DJ, Smith-Warner SA, Jacobs ET, Alberts DS, Greenberg ER. A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology. 2009 Mar;136(3):832-41. doi: 10.1053/j.gastro.2008.12.007. Epub 2008 Dec 9.

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• Hassan C, Quintero E, Dumonceau JM, Regula J, Brandao C, Chaussade S, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gimeno-Garcia A, Hazewinkel Y, Jover R, Kalager M, Loberg M, Pox C, Rembacken B, Lieberman D; European Society of Gastrointestinal Endoscopy. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2013 Oct;45(10):842-51. doi: 10.1055/s-0033-1344548. Epub 2013 Sep 12.

  PMID: 24030244 BACKGROUND

• Cubiella J, Carballo F, Portillo I, Cruzado Quevedo J, Salas D, Binefa G, Mila N, Hernandez C, Andreu M, Teran A, Arana-Arri E, Ono A, Valverde MJ, Bujanda L, Hernandez V, Morillas JD, Jover R, Castells A. Incidence of advanced neoplasia during surveillance in high- and intermediate-risk groups of the European colorectal cancer screening guidelines. Endoscopy. 2016 Nov;48(11):995-1002. doi: 10.1055/s-0042-112571. Epub 2016 Aug 2.

  PMID: 27485482 BACKGROUND

• Mangas-Sanjuan C, Jover R, Cubiella J, Marzo-Castillejo M, Balaguer F, Bessa X, Bujanda L, Bustamante M, Castells A, Diaz-Tasende J, Diez-Redondo P, Herraiz M, Mascort-Roca JJ, Pellise M, Quintero E; Grupo de Cribado del Cancer Colorrectal de la Sociedad Espanola de Epidemiologia. Endoscopic surveillance after colonic polyps and colorrectal cancer resection. 2018 update. Gastroenterol Hepatol. 2019 Mar;42(3):188-201. doi: 10.1016/j.gastrohep.2018.11.001. Epub 2019 Jan 6. English, Spanish.

  PMID: 30621911 BACKGROUND

• Zorzi M, Senore C, Turrin A, Mantellini P, Visioli CB, Naldoni C, Sassoli De' Bianchi P, Fedato C, Anghinoni E, Zappa M, Hassan C; Italian colorectal cancer screening survey group. Appropriateness of endoscopic surveillance recommendations in organised colorectal cancer screening programmes based on the faecal immunochemical test. Gut. 2016 Nov;65(11):1822-1828. doi: 10.1136/gutjnl-2015-310139. Epub 2015 Aug 21.

  PMID: 26297727 BACKGROUND

• Lieberman DA, Holub J, Eisen G, Kraemer D, Morris CD. Utilization of colonoscopy in the United States: results from a national consortium. Gastrointest Endosc. 2005 Dec;62(6):875-83. doi: 10.1016/j.gie.2005.06.037.

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• Marzo-Castillejo M, Almeda J, Mascort JJ, Cunillera O, Saladich R, Nieto R, Pineiro P, Llagostera M, Cantero F, Segarra M, Puente D. Appropriateness of colonoscopy requests according to EPAGE-II in the Spanish region of Catalonia. BMC Fam Pract. 2015 Oct 26;16:154. doi: 10.1186/s12875-015-0369-8.

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• Greuter MJE, de Klerk CM, Meijer GA, Dekker E, Coupe VMH. Screening for Colorectal Cancer With Fecal Immunochemical Testing With and Without Postpolypectomy Surveillance Colonoscopy: A Cost-Effectiveness Analysis. Ann Intern Med. 2017 Oct 17;167(8):544-554. doi: 10.7326/M16-2891. Epub 2017 Oct 3.

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• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

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  PMID: 25025396 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

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; Behavior

Central Study Contacts

Joaquín Cubiella, MD PhD

CONTACT

0034988385824; joaquin.cubiella.fernandez@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be identified in population CRC secreening programs of Galicia, the Basque Country, the Region of Valencia and Murcia. We will considered individuals aged 50 to 65 years with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program. Patients will be randomly allocated to perform an annual FIT and colonoscopy if fecal hemoglobin concentration is ≥10µg/g, or to perform endoscopic surveillance. Patients will be also stratified into two groups: ≥5 adenomas or an adenoma ≥20mm and the rest of patients. Patients will be followed for a period of 10 years.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2035
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

ES (1)