Colorectal Cancer, Genetics ofPhase 4CRIBADONCT01557101
Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population
A Phase 4 study testing COLON CAPSULE ENDOSCOPY ADHERENCE and OPTICAL COLONOSCOPY ADHERENCE in people with Colorectal Cancer, Genetics of, run by Hospital Universitario de Canarias at 2 sites in Spain.
Trial summary
The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Genetics of
- What is being tested?
- COLON CAPSULE ENDOSCOPY ADHERENCE and OPTICAL COLONOSCOPY ADHERENCE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2012to Jun 2013
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age.
- Signing of informed consent.
Who cannot join
- Personal history of adenoma or CRC.
- History of hereditary CRC.
- Chronic inflammatory disease.
- Presence of digestive symptoms.
- Patients with swallowing problems (dysphagia).
- Personal history of gastrointestinal surgery.
Show all 15Show fewer
- Enteritis radioactive.
- Renal failure.
- Congestive heart failure
- Allergy or other contraindication to Bysacodyl to PEG or phosphates.
- Pregnancy.
- Suspected bowel obstruction or intestinal strictures or fistulas known.
- Colectomy.
- Paralysis with impaired intestinal motility.
- Any other process that the investigator's discretion to make inadequate participation.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Digestive Service, Huc
San Cristóbal de La Laguna, S/c de Tenerife, 38320
Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/c de Tenerife, 38320
About this study
Official title: Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population
The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.
Read the detailed description
The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.
- Conditions
- Colorectal Cancer, Genetics of
- Being tested
- COLON CAPSULE ENDOSCOPY ADHERENCE, OPTICAL COLONOSCOPY ADHERENCE
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLON CAPSULE ENDOSCOPY ADHERENCEProcedure or surgery
An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.
OPTICAL COLONOSCOPY ADHERENCEProcedure or surgery
An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.
| Study group | Role | What they receive |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Other | Not described Receives: Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE |
| OPTICAL COLONOSCOPY | Other | Not described Receives: Procedure: OPTICAL COLONOSCOPY ADHERENCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer, Genetics ofStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Quintero, MD. PhD., Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557101
- Sponsor's protocol ID
- CEC_cribado_CCR
- Acronym
- CRIBADO
- Status last verified
- Jan 2014
- First submitted
- 13 Mar 2012
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Adrian-de-Ganzo Z, Alarcon-Fernandez O, Ramos L, Gimeno-Garcia A, Alonso-Abreu I, Carrillo M, Quintero E. Uptake of Colon Capsule Endoscopy vs Colonoscopy for Screening Relatives of Patients With Colorectal Cancer. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2293-301.e1. doi: 10.1016/j.cgh.2015.06.032. Epub 2015 Jun 29.
PubMed 26133904
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population
- ClinicalTrials.gov ID
- NCT01557101
- Acronym / sponsor ID
- CRIBADO / CEC_cribado_CCR
- Conditions
- Colorectal Cancer, Genetics of
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Mar 2012 (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.
The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.
Detailed description
The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COLON CAPSULE ENDOSCOPY | Other | Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE |
| OPTICAL COLONOSCOPY | Other | Procedure: OPTICAL COLONOSCOPY ADHERENCE |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age.
- Signing of informed consent.
Key exclusion criteria (15 listed)
- Personal history of adenoma or CRC.
- History of hereditary CRC.
- Chronic inflammatory disease.
- Presence of digestive symptoms.
- Patients with swallowing problems (dysphagia).
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 |
|---|---|---|
| COLON CAPSULE ENDOSCOPY ADHERENCEAn exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon. | Procedure or surgery | COLON CAPSULE ENDOSCOPY |
| OPTICAL COLONOSCOPY ADHERENCEAn exploration with an OPTICAL COLONOSCOPY from the anus to see the colon. | Procedure or surgery | OPTICAL COLONOSCOPY |
Primary outcome
Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
Time frame: 6 month follow up
Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
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 9 Jan 2014.
- Derived from this study: PubMed 26133904Adrian-de-Ganzo Z, Alarcon-Fernandez O, Ramos L, Gimeno-Garcia A, Alonso-Abreu I, Carrillo M, Quintero E. Uptake of Colon Capsule Endoscopy vs Colonoscopy for Screening Relatives of Patients With Colorectal Cancer. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2293-301.e1. doi: 10.1016/j.cgh.2015.06.032. Epub 2015 Jun 29.
Related trials for Colorectal Cancer, Genetics of
RecruitingPhase 2
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
T Cells, Colorectal Cancer
Recruiting
Family Communications After Genetic Testing
Colon Adenocarcinoma, Colorectal Adenocarcinoma
RecruitingObservational study
Development and Utilization of an Integrated Clinical Genomic Database
Gastric Cancer, Colorectal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast 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. PhD. principal investigator
Hospital Universitario de Canarias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COLON CAPSULE ENDOSCOPY ADHERENCE and OPTICAL COLONOSCOPY ADHERENCE in people with Colorectal Cancer, Genetics of, run by Hospital Universitario de Canarias at 2 sites 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 2 inclusion and 15 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 9 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 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer (time frame: 6 month follow up). 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 NCT01557101, which also lists 1 linked publication.
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 9 Jan 2014.