Early Detection of Five Common Cancers Using the ctDNA Analysing Test (K-DETEK)

October 16, 2023 updated by: Gene Solutions

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

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Hanoi, Vietnam
        • Recruiting
        • Hanoi Medical University
        • Contact:
          • Trang Dao, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers
Time Frame: 12 months following enrolment
12 months following enrolment
Sensitivity and specificity of the test in early detecting cancers
Time Frame: 12 months following enrolment
12 months following enrolment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
12 months following enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2022

Primary Completion (Estimated)

October 10, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation than authorized in the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer, Breast

3
Subscribe