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

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ClinicalTrials.gov Identifier: NCT05227261
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : October 17, 2023
Sponsor:
Collaborators:
Medical University of Ho Chi Minh City
Hanoi Medical University
Hanoi Oncology Hospital
Hue Central Hospital
Da Nang Oncology Hospital
Thong Nhat Dong Nai General Hospital
Dong Nai General Hospital
Van Hanh General Hospital
Can Tho Oncology Hospital
Medic Medical Center
Le Van Thinh Hospital
People's Hospital 115
Xuyen A Hospital
Medical Genetics Institute
Information provided by (Responsible Party):
Gene Solutions

Tracking Information
First Submitted Date January 26, 2022
First Posted Date February 7, 2022
Last Update Posted Date October 17, 2023
Actual Study Start Date April 10, 2022
Estimated Primary Completion Date October 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2022)
  • Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers [ Time Frame: 12 months following enrolment ]
  • Sensitivity and specificity of the test in early detecting cancers [ Time Frame: 12 months following enrolment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 26, 2022)
  • 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 ]
  • Rate of cancer development in the high-risk group as compared to the moderate-risk population [ Time Frame: 12 months following enrolment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.
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.
Condition
  • Cancer, Lung
  • Cancer, Breast
  • Cancer Liver
  • Cancer, Colorectal
  • Liquid Biopsy
  • Circulating Tumour DNA
  • Cancer, Gastric
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2023)		 10000
Original Estimated Enrollment
 (submitted: January 26, 2022)		 1643
Estimated Study Completion Date December 2023
Estimated Primary Completion Date October 10, 2023   (Final data collection date for primary outcome measure)
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 dementia.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Le-Son Tran +84705196257 sontran@genesolutions.vn
Contact: Thi Van Phan vanphan@genesolutions.vn
Listed Location Countries Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT05227261
Other Study ID Numbers 02GS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Current Responsible Party Gene Solutions
Original Responsible Party Same as current
Current Study Sponsor Gene Solutions
Original Study Sponsor Same as current
Collaborators
  • Medical University of Ho Chi Minh City
  • Hanoi Medical University
  • Hanoi Oncology Hospital
  • Hue Central Hospital
  • Da Nang Oncology Hospital
  • Thong Nhat Dong Nai General Hospital
  • Dong Nai General Hospital
  • Van Hanh General Hospital
  • Can Tho Oncology Hospital
  • Medic Medical Center
  • Le Van Thinh Hospital
  • People's Hospital 115
  • Xuyen A Hospital
  • Medical Genetics Institute
Investigators Not Provided
PRS Account Gene Solutions
Verification Date September 2023