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Trial record 18 of 562 for:    Genetic AND family history

Adding Family History of Colorectal Cancer to the Dutch FIT-based Screening Program

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ClinicalTrials.gov Identifier: NCT02698462
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Dutch Digestive Diseases Foundation
Information provided by (Responsible Party):
Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
The aim of this study is to identify more persons with advanced neoplasia in the current national CRC screening, by adding data on family history of CRC (using a validated online questionnaire) to FIT. In addition, the aim is to identify those persons and their family members who should not be participating in a FIT based screening but receive surveillance colonoscopies instead, because of a familial CRC syndrome. It is aimed to increase detection without affecting participation, thereby increasing the yield of screening.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Other: Family history questionnaire Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5979 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Adding Family History of Colorectal Cancer to the FIT-based Screening Program in a Dutch Colorectal Cancer Population Sample
Actual Study Start Date : April 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
FIT and Questionnaire
Six thousand persons eligible for the national CRC screening program will be selected. They will be selected from four areas that are considered representative of the Netherlands. All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.
Other: Family history questionnaire
All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT (cut-off value 275 ng/ml) and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.




Primary Outcome Measures :
  1. Diagnostic yield [ Time Frame: 1.5 years ]
    number of participants in whom advanced neoplasia is detected relative to the number of invitees


Secondary Outcome Measures :
  1. Participation rate [ Time Frame: 1.5 years ]
    Number of invitees completing the screening tests relative to the number of invitees

  2. Positive predictive value [ Time Frame: 1.5 years ]
    Number of participants in whom advanced neoplasia is detected, relative to the number of participants testing positive


Other Outcome Measures:
  1. The number of invitees with a familial CRC syndrome [ Time Frame: 1.5 years ]
  2. FIT result of participants with a familial CRC syndrome [ Time Frame: 1.5 years ]
  3. The number of family members of participants with a familial CRC syndrome who receive an advice for genetic testing and/or surveillance colonoscopies [ Time Frame: 1.5 years ]
  4. The number of questionnaire participants who need help completing the questionnaire [ Time Frame: 1.5 years ]
  5. The number of persons with a positive questionnaire with a confirmed familial CRC syndrome [ Time Frame: 1.5 years ]
  6. The number of persons with a false-positive questionnaire as confirmed when verifying the completed questionnaire [ Time Frame: 1.5 years ]
  7. The number of persons with a false-negative questionnaire as confirmed when verifying the completed questionnaire in a random sample of those with a negative questionnaire [ Time Frame: 1.5 years ]
  8. Attendance rate to the intake visit at the department of clinical genetics [ Time Frame: 1.5 years ]
  9. Reasons for non-participation to genetic testing after a familial CRC risk [ Time Frame: 1.5 years ]
    This will be analyzed in a telephone interview

  10. Attendance rate to the pre-colonoscopy consultation after a positive FIT or a familial CRC syndrome [ Time Frame: 1.5 years ]
  11. Reasons for non-participation to colonoscopy after a positive FIT or a familial CRC syndrome [ Time Frame: 1.5 years ]
    This will be analyzed in a telephone interview

  12. The number of persons with non-advanced lesions (SSA/P, hyperplastic polyps, non-advanced adenomas) after a positive FIT or a familial CRC syndrome [ Time Frame: 1.5 years ]
  13. Comparison of diagnostic yield in detecting advanced neoplasia of FIT with the national CRC screening yield [ Time Frame: 1.5 years ]


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Ages Eligible for Study:   59 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Six thousand persons eligible for the national CRC screening program, consisting of persons from the birth years 1941, 1945, 1953, 1955 and 1957 will be selected. These persons will be selected from four areas in North-Holland that are considered representative of the Netherlands regarding ethnical distribution and socioeconomic status: Aalsmeer, De Ronden Venen, Ouder-Amstel, Stichtse Vecht. These areas had an average participation-rate in 2014 that was comparable to the national participation rate (68.2%; a range from 65% to 75% is allowed). The distribution of age groups and gender will be comparable to the national screening distribution in 2016. Those who have been invited for a previous screening round in 2014 or for previous pilot-screening rounds will not be selected. In order to be eligible for participation, a subject must have been selected for participation in the national FIT-screening program in 2016.

Exclusion Criteria:

No specific exclusion criteria apply for participation in Family Matters, meaning that all invitees will receive a FIT as well as the questionnaire.


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): NCT02698462


Sponsors and Collaborators
Prof. Evelien Dekker, MD, PhD
Dutch Digestive Diseases Foundation
Investigators
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Principal Investigator: Evelien Dekker, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Prof. Evelien Dekker, MD, PhD, Professor MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02698462     History of Changes
Other Study ID Numbers: 821748-140305-PG
TC 12-05 ( Other Grant/Funding Number: Dutch Digestive Foundation )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Advanced neoplasia
Colorectal cancer
Population screening
Family history

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