Early Detection of Five Common Cancers Using the ctDNA Analysing Test (K-DETEK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05227261|
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : November 29, 2022
This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).
Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers.
- To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests.
- To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.
|Condition or disease|
|Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorectal Liquid Biopsy Circulating Tumour DNA Cancer, Gastric|
This is a multi-centre, prospective cohort study recruiting participants aged 40 or above, who present at the Outpatient Clinic of the study hospitals either for periodically follow-up visits for their chronic conditions, or for annually health check-up. The study will be conducted at the Medical Genetic Institute, in collaboration with the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam and other collaborating hospitals.
The potential participants, who satisfy all inclusion/exclusion criteria will be recruited into this study. These potential participants should not have history of cancer before being enrolled in the study.
At enrolment, each participant will answer to a pre-designed questionnaire to provide demographic information, past major medical history and clinical warning signs of cancers, and then provide 10mL of blood for analysing the circulating tumour DNA (ctDNA).
Each participant will get either ctDNA detected or ctDNA not detected.
For those having ctDNA detected in their blood, they will then undergo the screening and diagnostic tests for cancers based on the prediction of tumour origin provided in the test findings report. If the cancers lab-confirmed, patients will then be followed up and managed for their disease according to the guidelines of the Vietnam Ministry of Health and/or the international guidelines on cancers. At 12 months (+/- 1 week) following the enrolment, these patients will be contacted to collect information about their health, in general and their cancer status, in particular.
For those having ctDNA detected in their blood but the present of a mass inside participants' body could not be detected using the imaging diagnostic tests; and for those, who don't have ctDNA presenting in blood, phone calls will be made at 6 months (+/- 1 week) and 12 months (+/- 1 week) following the enrolment to collect information related to participants' health status as well as cancer progress (if possible).
The enrolment is anticipated to last for approximately 6 months.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA|
|Actual Study Start Date :||April 10, 2022|
|Estimated Primary Completion Date :||October 10, 2023|
|Estimated Study Completion Date :||December 2023|
- Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers [ Time Frame: 12 months following enrolment ]
- Sensitivity and specificity of the test in early detecting cancers [ Time Frame: 12 months following enrolment ]
- Positive predictive value of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests [ Time Frame: 12 months following enrolment ]
- Rate of cancer development in the high-risk group as compared to the moderate-risk population [ Time Frame: 12 months following enrolment ]
Biospecimen Retention: Samples With DNA
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): NCT05227261
|Contact: Le-Son Tranemail@example.com|
|Contact: Thi Van Phanfirstname.lastname@example.org|
|Hanoi medical university||Recruiting|
|Contact: Trang Dao, Dr|