Colorectal CancerPhase 3COLONFAMNCT01075633
Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
A Phase 3 study testing Immunochemical fecal occult blood test And colonoscopy if test is positive and Colonoscopy with sedation in people with Colorectal Cancer, run by Enrique Quintero at 1 site in Spain.
Trial summary
This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening in familiar-risk population and; 2) to determine the complications associated with both strategies. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Immunochemical fecal occult blood test And colonoscopy if test is positive and Colonoscopy with sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,501 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Jun 2013
- Phase
- Phase 3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 40-75 years, first degree relatives of patients with non-syndromic CRC
Who cannot join
- Personal history of CRC, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320
About this study
Official title: Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening in familiar-risk population and; 2) to determine the complications associated with both strategies.
Read the detailed description
This is an observational, controlled, randomized phase III study to evaluate the effectiveness of the iFOBT for detecting advanced neoplasia (polyps > 1cm in size, high grade dysplasia or with villous component, or CRC) in first degree relatives of patients with CRC.
Index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. Index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy, individuals randomized to group B will be invited to undergo a complete colonoscopy following two years follow-up. In addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded.
To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744
- Conditions
- Colorectal Cancer
- Being tested
- Immunochemical fecal occult blood test And colonoscopy if test is positive, Colonoscopy with sedation
- Keywords
- FOBT, colonoscopy, familiar risk, colorectal cancer, advanced adenoma
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunochemical fecal occult blood test And colonoscopy if test is positiveProcedure or surgery
Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Colonoscopy with sedationProcedure or surgery
Colonoscopy with sedation
| Study group | Role | What they receive |
|---|---|---|
| Fecal occult blood testing | Experimental | Immunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml. Receives: Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positive |
| Colonoscopy | Active comparator | Colonoscopy with sedation. Receives: Procedure: Colonoscopy with sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]
Measured: 2 years
Secondary outcomes (1)
Complications rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startJan 2006
- Primary completionDec 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrique Quintero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enrique Quintero, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
- Investigators
- Enrique Quintero, MD, Study director, Fundación Canaria para la Investigación Biomédica Rafael Clavijo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075633
- Sponsor's protocol ID
- COLONFAM
- Acronym
- COLONFAM
- Status last verified
- Jan 2014
- First submitted
- 24 Feb 2010
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gimeno-Garcia AZ, Quintero E, Nicolas-Perez D, Hernandez-Guerra M, Parra-Blanco A, Jimenez-Sosa A. Screening for familial colorectal cancer with a sensitive immunochemical fecal occult blood test: a pilot study. Eur J Gastroenterol Hepatol. 2009 Sep;21(9):1062-7. doi: 10.1097/MEG.0b013e3283293797.
PubMed 19307978Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
PubMed 25127679
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
- ClinicalTrials.gov ID
- NCT01075633
- Acronym / sponsor ID
- COLONFAM / COLONFAM
- Conditions
- Colorectal Cancer
- Keywords
- FOBT, colonoscopy, familiar risk, colorectal cancer, advanced adenoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,501 participants (actual)
- Lead sponsor
- Enrique QuinteroUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Feb 2010 (estimated)
- 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.
This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening in familiar-risk population and; 2) to determine the complications associated with both strategies.
Detailed description
This is an observational, controlled, randomized phase III study to evaluate the effectiveness of the iFOBT for detecting advanced neoplasia (polyps > 1cm in size, high grade dysplasia or with villous component, or CRC) in first degree relatives of patients with CRC.
Index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. Index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy, individuals randomized to group B will be invited to undergo a complete colonoscopy following two years follow-up. In addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded.
To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal occult blood testing | Experimental | Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positiveImmunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml. |
| Colonoscopy | Active comparator | Procedure: Colonoscopy with sedationColonoscopy with sedation. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 40-75 years, first degree relatives of patients with non-syndromic CRC
Key exclusion criteria (1 listed)
- Personal history of CRC, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunochemical fecal occult blood test And colonoscopy if test is positiveAnnual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml. | Procedure or surgery | Fecal occult blood testing |
| Colonoscopy with sedationColonoscopy with sedation | Procedure or surgery | Colonoscopy |
Primary outcome
Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]
Time frame: 2 years
1 secondary outcome
Complications rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Results publication: PubMed 19307978Gimeno-Garcia AZ, Quintero E, Nicolas-Perez D, Hernandez-Guerra M, Parra-Blanco A, Jimenez-Sosa A. Screening for familial colorectal cancer with a sensitive immunochemical fecal occult blood test: a pilot study. Eur J Gastroenterol Hepatol. 2009 Sep;21(9):1062-7. doi: 10.1097/MEG.0b013e3283293797.
- Derived from this study: PubMed 25127679Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Enrique Quintero, MD study director
Fundación Canaria para la Investigación Biomédica Rafael Clavijo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunochemical fecal occult blood test And colonoscopy if test is positive and Colonoscopy with sedation in people with Colorectal Cancer, run by Enrique Quintero at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No] (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075633, which also lists 2 linked publications.
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 8 Jan 2014.