Early Detection of Five Common Cancers Using the ctDNA Analysing Test

Cancer, Breast Clinical Trial

— K-DETEK  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227261
• Other study ID #: 02GS
• Status: Recruiting
• Start date: April 10, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Gene Solutions
• Contact: Le-Son Tran
• Phone: +84705196257
• Email: sontran[@]genesolutions.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Liver
• Cancer, Breast
• Cancer, Colorectal
• Cancer, Gastric
• Cancer, Lung
• Circulating Tumour DNA
• Colorectal Neoplasms
• Liquid Biopsy
• Lung Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
Vietnam	Hanoi medical university	Hanoi

Sponsors (15)

Lead Sponsor	Collaborator
Gene Solutions	Can Tho Oncology Hospital, Da Nang Oncology Hospital, Dong Nai General Hospital, Hanoi Medical University, Hanoi Oncology Hospital, Hue Central Hospital, Le Van Thinh Hospital, Medic Medical Center, Medical Genetics Institute, Medical University of Ho Chi Minh City, People's Hospital 115, Thong Nhat Dong Nai General Hospital, Van Hanh General Hospital, Xuyen A Hospital

Country where clinical trial is conducted

Vietnam, 

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers		12 months following enrolment
Primary	Sensitivity and specificity of the test in early detecting cancers		12 months following enrolment
Secondary	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
Secondary	Rate of cancer development in the high-risk group as compared to the moderate-risk population		12 months following enrolment

External Links

•   World Health Organization. Firm action is needed to eliminate viral hepatitis in Viet Nam. 2017
•   World Health Organization. Vietnam: International Agency for Research on Cancer. 2021