Colorectal Cancer Clinical Trial
— FR-QUENTOfficial title:
Identifying the Risk of Hereditary and Familial Colorectal Cancer in Colorectal Cancer Patients by Using an Online Risk Tool: An Evaluation Based on a Stepped Wedge Design
Verified date | July 2017 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this trial the investigators will evaluate the effectiveness of the implementation of a digital familial risk questionnaire in the detection of CRC patients with hereditary or familial CRC. This will be done using a stepped wedge design with 5 participating hospitals for a duration of 1.5 years. A comparison is made between an intervention phase (offering the online risk assessment questionnaire) and a control phase (hospital-based standard practice for the detection of CRC patients with hereditary or familial CRC, informed by the referral criteria that are being used in the intervention group). All patients with a diagnosis of CRC who have a first appointment at the CRC outpatient clinic will be included. The primary outcome is the percentage of all included patients who receive a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist. Data from clinical geneticists is being used to answer this question.
Status | Completed |
Enrollment | 104 |
Est. completion date | October 30, 2016 |
Est. primary completion date | April 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with a diagnosis of CRC who have a first appointment at the outpatient clinic (before treatment has started). If a patient undergoes surgery before going to an outpatient clinic (in case of an acute surgery indication), this patient will not be included in our study Exclusion Criteria: - Patients who have received a CRC treatment before their intake visit will be excluded |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Prof. Evelien Dekker, MD, PhD | Dutch Digestive Diseases Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of all included patients who have received a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist. | After 1.5 years (study completion) | ||
Secondary | Percentage of all included patients with a referral to a clinical geneticist | After 1.5 years (study completion) | ||
Secondary | Percentage of referred patients fulfilling referral criteria for a Lynch syndrome suspicion | After 1.5 years (study completion) | ||
Secondary | Percentage of all included patients with genetically confirmed Lynch syndrome | After 1.5 years (study completion) | ||
Secondary | Percentage of all included patients with confirmed other hereditary CRC syndromes (such as polyposis syndromes) | After 1.5 years (study completion) | ||
Secondary | Percentage of referred patients fulfilling FCC criteria | After 1.5 years (study completion) | ||
Secondary | Percentage of all included patients who receive a surveillance advice per time period (month or season) | After 1.5 years (study completion) | ||
Secondary | Percentage of referred patients not fulfilling referral criteria for FCC, a Lynch syndrome suspicion or other hereditary CRC syndromes | After 1.5 years (study completion) | ||
Secondary | Percentage of patients not adhering to referral advice | After 1.5 years (study completion) | ||
Secondary | The number of changes in family history after verification of the completed questionnaire at the outpatient clinic | After 1.5 years (study completion) | ||
Secondary | Patients' reasons for not filling out the questionnaire as reported by a nurse or gastroenterologist | After 1.5 years (study completion) | ||
Secondary | Usability of the questionnaire for health care providers and patients by using a self-created online or paper questionnaire | After 1.5 years (study completion) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |