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Trial record 1 of 3 for:    22356323 [PUBMED-IDS]
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Uptake to Colorectal Cancer Screening in Familial-risk Population

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ClinicalTrials.gov Identifier: NCT02567045
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Brief Summary:

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Uptake of Colonoscopy and FIT Procedure: annual FIT and colonoscopy in case of a positive test Procedure: colonoscopy with sedation Not Applicable

Detailed Description:

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.

The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1076 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Participants were randomized to either colonoscopy or faecal occult blood test
Primary Purpose: Screening
Official Title: Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy
Actual Study Start Date : February 25, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fecal occult blood testing

Annual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces.

Colonoscopy will be performed in case of a positive FIT.

Procedure: annual FIT and colonoscopy in case of a positive test
FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.

Procedure: colonoscopy with sedation
One-time Colonoscopy with sedation.

Active Comparator: one-time Colonoscopy
One-time Colonoscopy with sedation
Procedure: colonoscopy with sedation
One-time Colonoscopy with sedation.




Primary Outcome Measures :
  1. Proportion of patients who participate in each screening arm [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Efficacy measure: QALYs (Quality adjusted life years). [ Time Frame: 2 years ]
  2. Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. FDR with a case index meeting the following conditions: at least one case index < 60 years at diagnosis of the CCR;
  2. having ≥ 2 FDRs with CRC regardless the age of the case index at diagnosis;
  3. having a sibling with CRC;
  4. age <75 years.

Exclusion Criteria:

  1. past CRC screening;
  2. inflammatory bowel disease or past history of colorectal neoplasia;
  3. Family history of hereditary CRC;
  4. Abdominal symptoms;
  5. Colectomy;
  6. Severe comorbidity leading to a poor prognosis (life expectancy < 5 years);
  7. Refusal to participate in the study.

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): NCT02567045


Contacts
Contact: Antonio Z. Gimeno, MD, PhD +34922678039 antozeben@gmail.com

Locations
Spain
Federico Sopeña Biarge Recruiting
Zaragoza, Aragón, Spain, 50009
Sub-Investigator: Pilar Roncales Lazaro, MD         
Cristina Alvarez Urturi, MD Recruiting
Barcelona, Cataluña, Spain, 08003
Contact: Cristina Alvarez Urtur, MD         
Maria Teresa Ocaña Bombardo Recruiting
Barcelona, Cataluña, Spain, 08036
Contact: María T Ocaña Bombardo, MD         
Inés Castro Novo Recruiting
Ourense, Galicia, Spain, 32005
Patricia Muñoz Garrrido Recruiting
San Sebastián, País Vasco, Gipuzcoa, Spain, 20080
Contact: Patricia Muñoz Garrrido, MD         
Digestive Service, Huc Recruiting
La Laguna, S/c de Tenerife, Spain, 38320
Contact: ENRIQUE QUINTERO, MD. PhD.    615553711    equintero@gmail.com   
Principal Investigator: ENRIQUE QUINTERO, MD. PhD.         
Sub-Investigator: Antonio Z Gimeno García, MD PhD         
Sub-Investigator: Zaida Adrián de Ganzo, MD PhD         
Sub-Investigator: David N Pérez, MD PhD         
Sub-Investigator: Marta Carrillo Palau, MD PhD         
María Rodriguez Soler Recruiting
Alicante, Spain, 03010
Contact: María Rodriguez Soler, MD         
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Study Director: Enrique Quintero, MD, PhD Hospital Universitario de Canarias

Publications of Results:

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT02567045     History of Changes
Other Study ID Numbers: Colorectal cancer screening
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Hospital Universitario de Canarias:
Immunochemical fecal occult blood test
Colonoscopy
Screening uptake
Screening participation
Familiar risk
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases