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Characterization of Brazilian Colorectal Cancer Screening Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355391
Recruitment Status : Unknown
Verified August 2017 by Barretos Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Barretos Cancer Hospital

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.

Condition or disease
Colorectal Cancer Adenoma Colon

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of a Data System to Better Characterize Brazilian Colorectal Cancer Screening Population
Estimated Study Start Date : January 30, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Screening participants
Individuals aged 50 to 65 years who were included in the screening program of Cancer Hospital of Barretos



Primary Outcome Measures :
  1. colorectal cancer rate [ Time Frame: 12 months ]
    number of participants with colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (FIT)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355391


Contacts
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Contact: Denise Guimaraes, MD, PhD 551733216600 ext 7267 guimaraes.dp@gmail.com

Sponsors and Collaborators
Barretos Cancer Hospital
Duke University
Investigators
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Principal Investigator: Denise Guimaraes, MD, PhD Barretos Cancer Hospital
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Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT03355391    
Other Study ID Numbers: BarretosCH-20172
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barretos Cancer Hospital:
SCREENING
RISK FACTOR
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type