Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Lung Neoplasms

Colorectal Neoplasms

Stomach Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Stomach Cancer

Le-Son Tran

Thi Van Phan

Trang Dao, Dr

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.

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.

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.

Early Detection of Five Common Cancers Using the ctDNA Analysing Test

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

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.

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

Gene Solutions

Liver Neoplasms

Liver Diseases

Le Son Tran, Ph.D

To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals, the investigators sought to launch a prospective multicenter study, named K-ACCELERATE. The study aims to recruit 1,000 participants who develop symptoms and signs specific to the top five common cancer types including breast, colorectal, gastric, liver and lung cancer.

Primary objective: Evaluate the performance of the SPOT-MAS test in detecting cancer in symptomatic populations.

Secondary objectives: Evaluate the feasibility of incorporating SPOT-MAS as a triage test into primary care to increase the detection rates of malignant cancer while minimizing unnecessary referrals to invasive procedures.

Participants are recruited and referred to one of the five diagnosis pathways according to the participants' symptoms and signs listed.

Before undertaking imaging tests, 10 ml of blood is collected in Streck tube for SPOT-MAS test.

Participants undertake low-resolution imaging (LRI) tests matching with participants' referral diagnosis pathway. Imaging test results are returned within the same day.

If participants get negative results from both SPOT-MAS and LRI, participants will receive treatment for the symptoms based on the standard treatment scheme at hospitals and be followed up for 12 months to confirm their cancer-free status.

- If participants get a positive result from either SPOT-MAS or LRI, participants will be referred to high-resolution imaging tests (HRI) or tissue biopsy to confirm the presence of tumor.

For those with positive results confirming invasive tumors by HRI or tissue biopsy, patients will undergo treatment. The investigators do not provide financial support for their treatment.

For those with no invasive lesions but having positive SPOT-MAS results, participants will be advised to re-take the SPOT-MAS test after 6 months.

If the 2nd SPOT-MAS test results return positive, participants will be advised to perform whole body CT scan. If participants' scanning results return positive, participants will undergo tissue biopsy and treatment.

If the 2nd SPOT-MAS or whole body CT scan is negative, participants will be followed-up for an additional 6 months by surveying to confirm the cancer-free status.

The enrolment is anticipated to last for approximately 6 months

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

Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)

K-ACCELERATE: A Multi-center Prospective Trial to Evaluate Clinical Utility of Multi Cancer Early Detection Test as a Triage Test for Symptomatic Participants

Sensitivity, Specificity, Positive predictive value, Negative predictive value of the SPOT-MAS test

accuracy of tumor tissue origin identification

Positive predictive value, Negative predictive value, Sensitivity and Specificity of the SPOT-MAS test in combination with LRI and HRI tests

University of Medicine and Pharmacy at Ho Chi Minh City

Patients with a pathological confirmation of GC diagnosis

The study uses a case-control design that examines the differences in types of exposures between cases defined with a pathological confirmation of GC diagnosis, and controls, defined as patients to whom a gastroscopy was indicated and confirmed absent of GC i

GC is associated to several known risk factors. Epidemiological and molecular features of GCs can vary widely. The reasons behind these differences are multiple and complex and may include genetic susceptibility, strains of the bacterium Helicobacter pylori (H. pylori), Epstein Barr virus infection, dietary factors and others. These factors can influence GC outcomes. There is little knowledge regarding how these risk factors are associated with GC in CELAC and EU populations.

The primary objectives of this study are to:

1. Identify risk factors associated with GC in the CELAC and EU populations participating in this study including Argentina, Spain, Mexico, Netherlands, Chile, Portugal and Paraguay.
2. Identify clinical, demographic, and epidemiological differences among the populations participating in this study

Gastric Cancer Risk Factors Associated With EU and CELAC Populations

The ratio of the odds of exposure vs. odds of no exposure to a variety of potential sources of GC risk factors in cases vs. controls.

Instituto Nacional de Cancerologia de Mexico

Amsterdam UMC, location VUmc

Pontificia Universidad Catolica de Chile

Vall d'Hebron Institute of Oncology

INSTITUTO ALEXANDER FLEMING

Hospital Central del IPS

IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

Fundación para la Investigación del Hospital Clínico de Valencia

Study title	NCT ID	Conditions	Eligibility	Organization
Early Detection of Five Common Cancers Using the ctDNA Analysing Test	NCT05227261	Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorec... Liquid Biopsy Circulating Tum... Cancer, Gastric	40 Years -	Gene Solutions
Early Detection of Five Common Cancers Using the ctDNA Analysing Test	NCT05227261	Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorec... Liquid Biopsy Circulating Tum... Cancer, Gastric	40 Years -	Gene Solutions
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)	NCT06391749	Cancer Colon Cancer, Liver Cancer, Lung Cancer, Breast Cancer, Gastric	18 Years -	Gene Solutions
Gastric Cancer Risk Factors Associated With EU and CELAC Populations	NCT03957031	Cancer, Gastric	18 Years - 90 Years	Fundación para la Investigación del Hospital Clínico de Valencia
Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)	NCT06391749	Cancer Colon Cancer, Liver Cancer, Lung Cancer, Breast Cancer, Gastric	18 Years -	Gene Solutions

Spots Global Cancer Trial Database for cancer, gastric