Blood sampling
Diagnostic TestPreveCol test based on blood sampling
Other names: PreveCol
NCT Number: NCT06703632
The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:
* Values of efficacy, efficiency, impact and safety of PreveCol. * Values of preferences of participants for screening methods. * Values of PREMs into screening programme.
Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
Interested in participating?
Request Info50 year–69 year
All sexes
Interventional
Not applicable
Hospital de Santa Maria, Lisbon, Lisbon District, Portugal
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PreveCol test based on blood sampling
Other names: PreveCol
Preference questionnaire for colorectal cancer screening methods
Time frame: 12 months
Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions.
Time frame: 12 months
Value of PreveCol's efficiency in second line for detecting cancer
Time frame: 12 months
Value of PreveCol's efficiency in second line for advanced lesions
Time frame: 12 months
The percentage of number of answers from each preference questions and PREMs
Time frame: 12 months
Measure the percentage of adverse events and complications directly/indirectly related to interventions of study.
Contact information is provided by the study sponsor or research team.
ADVANCED MARKER DISCOVERY S.L.
Industry
Acronym: MS-Prevecol
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06696534
Colonic Diseases, Colorectal Neoplasms
Lisbon, Portugal
View Trial DetailsNCT01790425
Screening for Colon Cancer
Sacramento, California, United States
View Trial DetailsNCT06640166
Colon Adenocarcinoma, Colon Cancer
Milan, Italy
View Trial DetailsNCT02863107
Colon Adenocarcinoma, Colonic Diseases
Conroe, Texas, United States
View Trial Details