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

Cancer Clinical Trial

— ASCEND-Gastric  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224596
• Other study ID #: B2020-390R
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: January 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Yihong Sun, MD
• Phone: +86-021-65642662
• Email: sun.yihong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 498
• Est. completion date: September 22, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Blood draw and blood-based biomarkers analyses
blood-based biomarkers analyses

Locations

Country	Name	City	State
China	ZhongShan hospital FuDan university	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Guangzhou Burning Rock Bioengineering Ltd

Country where clinical trial is conducted

China, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity and specificity of a blood miRNA-based model in detecting gastric cancer.		30 months
Primary	Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer.		30 months
Secondary	The differences of sensitivity and specificity in gastric cancer participants at different clinical stages.		30 months
Secondary	Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers.		30 months
Secondary	Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively.		30 months