Characterization of Brazilian Colorectal Cancer Screening Population

NCT03355391 | Unknown

• 1 other identifier: BarretosCH-20172
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal cancer (CRC) is the third most common type of cancer among men and the second among women in Brazil. Despite the high incidence and significance of CRC in Brazil, very little is known about its prevalence among the asymptomatic population. Recently, a CRC screening program was implemented at the Cancer Hospital of Barretos. Characterization of the clinical findings detected in the screening population and the prevalence of basal CRC might contribute to better organization of the program and define the best strategy for a future national screening program. We hypothesize that recruitment and the early outcomes of our screening program based on the fecal immunochemical test (FIT) will differ from the outcomes corresponding to other populations due to sociodemographic differences. Aims: i. To implement a data collection and storage system for follow-up of the screening program participants and to measure early outcomes (adenoma, advanced adenoma and cancer) and associate them with sociodemographic risk factors; ii. to quantify the risk of CRC in the Brazilian population and to develop algorithms for risk stratification of CRC screening; and iii. to compare the risk stratification to other countries with low, medium and high incomes. Methods: Individuals aged 50 to 65 years will be included in the HCB screening program from November 2017 to December 2018. The following data will be collected from all participants: sociodemographic and ethnic (skin color) characteristics; risk factors for CRC, such as smoking and drinking; comorbidities, including diabetes mellitus and arterial hypertension; and FIT, colonoscopy and histopathology examination results. Data collection will be performed using the REDCap data collection/database system. The risk score will be formulated using the Chi-square test (or Fisher's exact test) and simple logistic regression, and the regression coefficients will be calculated. Then, the model identified for the training sample will be replicated with a validation sample. The resulting score will be used to calculate the sensitivity, specificity, positive predictive value, negative predictive value, accuracy, area under the receiver operating characteristic (ROC) curve and Kolmogorov D statistic.

Conditions

Colorectal Cancer; Adenoma Colon

Keywords

SCREENING; RISK FACTOR

Outcome Measures

Primary Outcomes (1)

• colorectal cancer rate

  number of participants with colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (FIT)

  12 months

Study Arms (1)

Screening participants

Individuals aged 50 to 65 years who were included in the screening program of Cancer Hospital of Barretos

Eligibility Criteria

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

Study Population

The target population was invited to participate in the screening program of the Department of Prevention, HCB. Recruitment will be performed among individuals attending HCB for the prevention of tumors other than CRC, the population of Barretos, who may who may learn about the program through the media or friends spontaneously visiting HCB, and participants of the neighborhood mobile unit and "door-to-door" screening program in Barretos

You may qualify if:

• Individuals aged 50 to 65 years who were included in the HCB screening program from November 2017 to December 2018.

You may not qualify if:

• Presence of signs and symptoms of CRC (rectal bleeding, recent change of the bowel pattern, abdominal mass or anemia).
• Family history of CRC.
• Personal history of adenoma or CRC

Sponsors & Collaborators

• Barretos Cancer Hospital: lead
• Duke University: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Denise Guimaraes, MD, PhD

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Guimaraes, MD, PhD

CONTACT

551733216600; guimaraes.dp@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: January 30, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 1, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share