Colorectal CancerNCT03355391
Characterization of Brazilian Colorectal Cancer Screening Population
An observational study of Colorectal Cancer and Adenoma Colon, run by Barretos Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenoma Colon
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2018to 1 Dec 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Individuals aged 50 to 65 years who were included in the HCB screening program from November 2017 to December 2018.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementation of a Data System to Better Characterize Brazilian Colorectal Cancer Screening Population
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.
Read the detailed description
Variables and data collection Upon entry into the program, 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 the FIT, colonoscopy and histopathology examination results.
Data collection will be performed using the REDCap electronic data capture tools hosted at Barretos Cancer Hospital (Paul et al., 2009). For this purpose, clinical forms were developed containing questions relative to the data to be analyzed in the present project.
Colonoscopy procedure Colonoscopies will be performed according to the routine procedures of the Department of Prevention Endoscopy, HCB. Bowel preparation will begin on the eve of the test and will consist of a residue-free liquid diet and oral intake of 10 mg of bisacodyl (5 mg/tablet, Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda, São Paulo, Brazil) at 2:00 and 6:00 pm. On the test day, preparation will begin 5 hours before the procedure and will consist of the oral intake of 500 ml of 20% mannitol.
Prior to the colonoscopy, the patients will be sedated with fentanyl (0.05 mg/ml - Cristália Produtos Químicos Farmacêuticos Ltda, São Paulo, Brazil), midazolam (5 mg/5 ml - Produtos Roche Químicos e Farmacêuticos S.A., Rio de Janeiro, Brazil) and propofol (10 mg/ml - Cristália Produtos Químicos Farmacêuticos Ltda, São Paulo, Brazil) via the intravenous route. Then, a flexible endoscope will be introduced up to the cecum and terminal ileum.
Oxygen will be supplied at a flow rate of 2 l/min throughout the procedure. The heart rate and oxygen saturation will be monitored. All tests will be performed using high-definition colonoscopes (Olympus 180), and CO2 insufflation will be performed by senior endoscopists with extensive experience in diagnostic colonoscopy.
The following data will be recorded throughout the procedure: colonoscope introduction and withdrawal times; quality of bowel preparation according to the Boston scale; and location and characteristics of the detected lesions. Accurate reports of the study outcomes (adenoma, advanced adenoma and carcinoma), including the number, size and precise location, will have paramount importance. The detected lesions will be classified following the Paris classification (Paris Classification, 2002) as follows: type 0-I, polypoid (0-Is: sessile; 0-Isp: sub-pedunculated; and 0-Ip: pedunculated) and type 0-II, non-polypoid (0-IIa: slightly elevated surface; 0-IIb: flat; 0-IIc: slightly depressed; and 0-III: excavated).
Statistical analysis All statistical analyses will be performed using the SPSS software for Windows, version 21.0. In all cases, the significance level will be set to 0.05.
The sample will be described in terms of the mean, standard deviation, minimum, maximum and quartiles for quantitative variables and through frequency tables in the case of qualitative variables.
The risk score will be formulated as follows:
The sample will be composed of individuals diagnosed or not with cancer. Individuals with adenoma or advanced adenoma and individuals without cancer will be excluded from the analysis. Cases with a negative FIT will be considered No Cancer. Cases with a positive FIT will be subjected to colonoscopy, the results of which will allow the classification of each participant as Cancer or No Cancer. The sample will be randomly divided into two groups. The first group will comprise 75% of the data and be named the training sample. The second group will comprise the remaining 25% of the data and be named the validation sample.
The training sample will be used to develop the risk score. First, the relationship of all of the participants' characteristics with the outcomes (Cancer/No Cancer) will be investigated using the Chi-square test (or Fisher's exact test) and simple logistic regression. All characteristics with a p-value less than 0.2 in the previous assessment and other characteristics that the investigators judge relevant will be included in a multiple logistic regression model; then, the regression coefficients will be calculated.
Next, the model identified for the training sample will be replicated with the 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.
If the model is considered discriminant, nomograms will be plotted, and risk groups will be defined based on the risk score.
- Conditions
- Colorectal Cancer, Adenoma Colon
- Keywords
- SCREENING, RISK FACTOR
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Screening participants | Individuals aged 50 to 65 years who were included in the screening program of Cancer Hospital of Barretos |
What is being measured
The primary outcome is the main question the study is designed to answer.
colorectal cancer rate
number of participants with colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (FIT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start30 Jan 2018 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Denise Guimaraes, MD, PhD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355391
- Sponsor's protocol ID
- BarretosCH-20172
- Status last verified
- Aug 2017
- First submitted
- 22 Nov 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Data System to Better Characterize Brazilian Colorectal Cancer Screening Population
- ClinicalTrials.gov ID
- NCT03355391
- Acronym / sponsor ID
- BarretosCH-20172
- Conditions
- Colorectal Cancer, Adenoma Colon
- Keywords
- SCREENING, RISK FACTOR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 30 Jan 2018 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 28 Nov 2017 (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.
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.
Detailed description
Variables and data collection Upon entry into the program, 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 the FIT, colonoscopy and histopathology examination results.
Data collection will be performed using the REDCap electronic data capture tools hosted at Barretos Cancer Hospital (Paul et al., 2009). For this purpose, clinical forms were developed containing questions relative to the data to be analyzed in the present project.
Colonoscopy procedure Colonoscopies will be performed according to the routine procedures of the Department of Prevention Endoscopy, HCB. Bowel preparation will begin on the eve of the test and will consist of a residue-free liquid diet and oral intake of 10 mg of bisacodyl (5 mg/tablet, Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda, São Paulo, Brazil) at 2:00 and 6:00 pm. On the test day, preparation will begin 5 hours before the procedure and will consist of the oral intake of 500 ml of 20% mannitol.
Prior to the colonoscopy, the patients will be sedated with fentanyl (0.05 mg/ml - Cristália Produtos Químicos Farmacêuticos Ltda, São Paulo, Brazil), midazolam (5 mg/5 ml - Produtos Roche Químicos e Farmacêuticos S.A., Rio de Janeiro, Brazil) and propofol (10 mg/ml - Cristália Produtos Químicos Farmacêuticos Ltda, São Paulo, Brazil) via the intravenous route. Then, a flexible endoscope will be introduced up to the cecum and terminal ileum.
Oxygen will be supplied at a flow rate of 2 l/min throughout the procedure. The heart rate and oxygen saturation will be monitored. All tests will be performed using high-definition colonoscopes (Olympus 180), and CO2 insufflation will be performed by senior endoscopists with extensive experience in diagnostic colonoscopy.
The following data will be recorded throughout the procedure: colonoscope introduction and withdrawal times; quality of bowel preparation according to the Boston scale; and location and characteristics of the detected lesions. Accurate reports of the study outcomes (adenoma, advanced adenoma and carcinoma), including the number, size and precise location, will have paramount importance. The detected lesions will be classified following the Paris classification (Paris Classification, 2002) as follows: type 0-I, polypoid (0-Is: sessile; 0-Isp: sub-pedunculated; and 0-Ip: pedunculated) and type 0-II, non-polypoid (0-IIa: slightly elevated surface; 0-IIb: flat; 0-IIc: slightly depressed; and 0-III: excavated).
Statistical analysis All statistical analyses will be performed using the SPSS software for Windows, version 21.0. In all cases, the significance level will be set to 0.05.
The sample will be described in terms of the mean, standard deviation, minimum, maximum and quartiles for quantitative variables and through frequency tables in the case of qualitative variables.
The risk score will be formulated as follows:
The sample will be composed of individuals diagnosed or not with cancer. Individuals with adenoma or advanced adenoma and individuals without cancer will be excluded from the analysis. Cases with a negative FIT will be considered No Cancer. Cases with a positive FIT will be subjected to colonoscopy, the results of which will allow the classification of each participant as Cancer or No Cancer. The sample will be randomly divided into two groups. The first group will comprise 75% of the data and be named the training sample. The second group will comprise the remaining 25% of the data and be named the validation sample.
The training sample will be used to develop the risk score. First, the relationship of all of the participants' characteristics with the outcomes (Cancer/No Cancer) will be investigated using the Chi-square test (or Fisher's exact test) and simple logistic regression. All characteristics with a p-value less than 0.2 in the previous assessment and other characteristics that the investigators judge relevant will be included in a multiple logistic regression model; then, the regression coefficients will be calculated.
Next, the model identified for the training sample will be replicated with the 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.
If the model is considered discriminant, nomograms will be plotted, and risk groups will be defined based on the risk score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening participants | – | –Individuals aged 50 to 65 years who were included in the screening program of Cancer Hospital of Barretos |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Individuals aged 50 to 65 years who were included in the HCB screening program from November 2017 to December 2018.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
colorectal cancer rate
Time frame: 12 months
number of participants with colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (FIT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Denise Guimaraes, MD, PhD principal investigator
Barretos Cancer Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Adenoma Colon, run by Barretos Cancer Hospital.
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 1 inclusion and 3 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Denise Guimaraes, MD, PhD (551733216600 ext. 7267, guimaraes.dp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colorectal cancer rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2018.