K-DETEK: Early Detection of Four Common Cancers Using the ctDNA Analysing Test

Sponsor

Gene Solutions (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05227261

Collaborator

Medical University of Ho Chi Minh City (Other), Hanoi Medical University (Other), Hanoi Oncology Hospital (Other), National K Hospital (Other), Hue Central Hospital (Other), Da Nang Oncology Hospital (Other), Thong Nhat Dong Nai General Hospital (Other), Dong Nai General Hospital (Other), Van Hanh General Hospital (Other), Can Tho Oncology Hospital (Other), Medic Medical Center (Other), Le Van Thinh Hospital (Other), People's Hospital 115 (Other), Xuyen A Hospital (Other)

1,643

Enrollment

Location

Anticipated Duration (Months)

82.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorectal Liquid Biopsy Circulating Tumour DNA

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1643 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of a Novel Blood Test in Early Detection of the Four Common Cancers Based on the Investigation of the Circulating Tumour DNA

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers [12 months following enrolment]
Sensitivity and specificity of the test in early detecting cancers [12 months following enrolment]

Secondary Outcome Measures

Positive predictive value of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests [12 months following enrolment]
Rate of cancer development in the high-risk group as compared to the moderate-risk population [12 months following enrolment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 dementia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanoi medical university	Hanoi		Vietnam

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Gene Solutions

ClinicalTrials.gov Identifier:

NCT05227261

Other Study ID Numbers:

01GS

First Posted:

Feb 7, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gene Solutions

Early cancer detection

Circulating Tumour DNA

Liquid biopsy

Vietnam

Additional relevant MeSH terms:

Breast Neoplasms

Lung Neoplasms

Colorectal Neoplasms

Study Results

No Results Posted as of May 2, 2022