Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05227261
Study type Observational
Source Gene Solutions
Contact Le-Son Tran
Phone +84705196257
Email sontran@genesolutions.vn
Status Recruiting
Phase
Start date April 10, 2022
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04416087 - Exercise and Tumor Blood Flow in Breast Cancer Patients N/A
Active, not recruiting NCT04726319 - Family History App in Personalized Medicine N/A
Recruiting NCT05800834 - Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds Phase 2
Completed NCT04692168 - Influence of Chemotherapy on Postural Control in Women With Cancer
Recruiting NCT06152419 - Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project N/A
Recruiting NCT03709134 - Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Completed NCT03282214 - A Self-Management Energy Conservation Program for Cancer-Related Fatigue Phase 2
Recruiting NCT06275321 - Physical Exercise Benefits for Cancer Patients N/A
Recruiting NCT05711030 - Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery N/A
Suspended NCT03271853 - Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis. N/A
Active, not recruiting NCT03144947 - Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients Phase 2
Completed NCT02996201 - Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial N/A
Recruiting NCT05573022 - Impact of a Patient Decision Aid Intervention N/A
Completed NCT05161312 - A Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients - a Randomised Clinical Trial N/A
Completed NCT04836221 - Comorbidities And Reducing inEquitieS N/A
Recruiting NCT06345534 - FAST-FORWARD vs HAI5 N/A
Recruiting NCT06391749 - Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)
Enrolling by invitation NCT06409221 - VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Not yet recruiting NCT03910283 - Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer N/A
Completed NCT03612934 - The Impact of SPC on Advanced Breast Cancer Patients