AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric

Study Overview
=================
Brief Summary
-----------------
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.

Official Title
-----------------
Gastric Cancer Detection by Liquid Biopsy in Peripheral Blood: A Prospective Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Blood draw and blood-based biomarkers analyses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Cancer Arm Participants: Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. No prior cancer treatment (local or systematic) with either of the following: A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw. B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw. Exclusion Criteria for Cancer Arm Participants: Insufficient qualified blood samples. During pregnancy or lactation. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. Recipient of blood transfusion within 7 days prior to blood draw. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw. With other known malignant tumors or multiple primary tumors. Inclusion Criteria for Benign Disease Arm Participants: Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Able to provide sufficient and qualified blood samples for study tests. Have either of the following: A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection. B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw. Exclusion Criteria for Benign Disease Arm Participants: Insufficient qualified blood sample for study test. During pregnancy or lactation. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. Recipient of blood transfusion within 7 days prior to study blood draw. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer arm<br>Baseline blood samples will be collected from new diagnosis cancer participants. | Diagnostic Test: Blood draw and blood-based biomarkers analyses<br>* blood-based biomarkers analyses<br>|
| Benign disease arm<br>Baseline blood samples will be collected from new diagnosis benign gastric disease participants. | Diagnostic Test: Blood draw and blood-based biomarkers analyses<br>* blood-based biomarkers analyses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer. |  | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of sensitivity and specificity in gastric cancer participants at different clinical stages. |  | 30 months | 
| Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers. |  | 30 months | 
| Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively. |  | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, liquid biopsy, cell-free DNA (cfDNA) methylation, circulating tumor DNA (ctDNA) mutation, whole blood miRNA