Clinical trial NCT05227261: Early Detection of Five Common Cancers Using the ctDNA Analysing Test
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Lung
Cancer, Breast
Cancer Liver
Cancer, Colorectal
Liquid Biopsy
Circulating Tumour DNA
Cancer, Gastric
Keywords: Early cancer detection
Circulating Tumour DNA
Liquid biopsy
Vietnam
Lead sponsor: Gene Solutions
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Ho Chi Minh City
name: Hanoi Medical University
name: Hanoi Oncology Hospital
name: Hue Central Hospital
name: Da Nang Oncology Hospital
name: Thong Nhat Dong Nai General Hospital
name: Dong Nai General Hospital
name: Van Hanh General Hospital
name: Can Tho Oncology Hospital
name: Medic Medical Center
name: Le Van Thinh Hospital
name: People's Hospital 115
name: Xuyen A Hospital
name: Medical Genetics Institute
First posted: 2022-02-07
Enrollment: 9057
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include both males and females, aged 40 or above, who have no history of cancer. These people present at the Outpatient Clinic of the study hospitals either for periodically follow-up visits for their chronic conditions or for health check-up.The eligible participants will have to satisfy all of the inclusion and exclusion criteria to be recruited into this study.

Brief summary: 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.

Secondary objectives:

* 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 40 or above at enrolment
* Neither clinical suspicion of cancer nor history of confirmed cancer has been reported
* Agree to be contacted at 6 months and 12 months following enrolment to collect information about general health status and progress of cancer (if possible)
* Provide written informed consent

Exclusion Criteria: If a potential participant has any one of the following criteria, he/she will not be able to be enrolled in the study:

* History of cancer (cancer has either been confirmed or been treated within the past 3 years)
* History of blood transfusion or bone marrow transplantation within the past 3 years
* Does not agree to participate in study
* The subject has clinical manifestations of pregnant.

Primary outcomes:
measure: Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers
timeFrame: 12 months following enrolment
measure: Sensitivity and specificity of the test in early detecting cancers
timeFrame: 12 months following enrolment
Secondary outcomes:
measure: Positive predictive value of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests
timeFrame: 12 months following enrolment
measure: Rate of cancer development in the high-risk group as compared to the moderate-risk population
timeFrame: 12 months following enrolment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi medical university
Study officials:
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