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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05227261
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : November 29, 2022
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

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

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 10, 2022
Estimated Primary Completion Date : October 10, 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine





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 ]

Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05227261


Contacts
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Contact: Le-Son Tran +84705196257 sontran@genesolutions.vn
Contact: Thi Van Phan vanphan@genesolutions.vn

Locations
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Vietnam
Hanoi medical university Recruiting
Hanoi, Vietnam
Contact: Trang Dao, Dr         
Sponsors and Collaborators
Gene Solutions
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
Additional Information:
Publications:
Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

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Responsible Party: Gene Solutions
ClinicalTrials.gov Identifier: NCT05227261    
Other Study ID Numbers: 01GS
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (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
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gene Solutions:
Early cancer detection
Circulating Tumour DNA
Liquid biopsy
Vietnam
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases