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History of Changes for Study: NCT05227261
Early Detection of Four Common Cancers Using the ctDNA Analysing Test (K-DETEK)
Latest version (submitted October 16, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 26, 2022 None (earliest Version on record)
2 April 26, 2022 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
3 November 23, 2022 Study Status, Oversight, Sponsor/Collaborators, Study Identification, Contacts/Locations, Study Design and Conditions
4 September 11, 2023 Study Status, Study Design and Study Identification
5 October 16, 2023 Study Status
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Study NCT05227261
Submitted Date:  January 26, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: 01GS
Brief Title: Early Detection of Four Common Cancers Using the ctDNA Analysing Test (K-DETEK)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2022
Overall Status: Not yet recruiting
Study Start: February 2022
Primary Completion: August 2023 [Anticipated]
Study Completion: December 2023 [Anticipated]
First Submitted: January 26, 2022
First Submitted that
Met QC Criteria:		 January 26, 2022
First Posted: February 7, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 January 26, 2022
Last Update Posted: February 7, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gene Solutions
Responsible Party: Sponsor
Collaborators: University of Medicine and Pharmacy at Ho Chi Minh City
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Cancer, Lung
Cancer, Breast
Cancer Liver
Cancer, Colorectal
Liquid Biopsy
Circulating Tumour DNA
Keywords: Early cancer detection
Circulating Tumour DNA
Liquid biopsy
Vietnam
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Samples collected from the participants will be processed and analysed the ctDNA to detect cancer in the early stages and to predict the origin of the tumor. The residual blood of this test will be stored in -80 degree of Celcius for further testing to:- (i) screen or diagnose cancers; (ii) determine the hosts' genetic factors associated with the risks of cancers.
Enrollment: 1643 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers
[ Time Frame: 12 months following enrolment ]
2. Sensitivity and specificity of the test in early detecting cancers
[ Time Frame: 12 months following enrolment ]
Secondary Outcome Measures:
1. 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 ]
2. Rate of cancer development in the high-risk group as compared to the moderate-risk population
[ Time Frame: 12 months following enrolment ]
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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 dementia.
Open or close this module Contacts/Locations
Central Contact Person: Le-Son Tran
Telephone: +84705196257
Email: sontran@genesolutions.vn
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
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.
Supporting Information:
Study Protocol
Informed Consent Form (ICF)
Time Frame:
Access Criteria:
URL:
Open or close this module References
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Links: Description: World Health Organization. Firm action is needed to eliminate viral hepatitis in Viet Nam. 2017
Description: World Health Organization. Vietnam: International Agency for Research on Cancer. 2021
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