AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric
NCT ID: NCT05224596
Last Updated: 2022-02-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
498 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-01-18
Study Completion Date
2022-09-22
Brief Summary
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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.
Detailed Description
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Conditions
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Cancer
Keywords
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Cancer
liquid biopsy
cell-free DNA (cfDNA) methylation
circulating tumor DNA (ctDNA) mutation
whole blood miRNA
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Cancer arm
Baseline blood samples will be collected from new diagnosis cancer participants.
Blood draw and blood-based biomarkers analyses
Intervention Type
DIAGNOSTIC_TEST
blood-based biomarkers analyses
Benign disease arm
Baseline blood samples will be collected from new diagnosis benign gastric disease participants.
Blood draw and blood-based biomarkers analyses
Intervention Type
DIAGNOSTIC_TEST
blood-based biomarkers analyses
Interventions
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Blood draw and blood-based biomarkers analyses
blood-based biomarkers analyses
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* 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.
* 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
* 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.
* 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.
* 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.
* 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.
Minimum Eligible Age
40 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Guangzhou Burning Rock Bioengineering Ltd.
INDUSTRY
Sponsor Role
collaborator
Shanghai Zhongshan Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Yihong Sun Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University,China
Xuefei Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University,China
Locations
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ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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Yihong Sun, MD
Role: primary
References
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Other Identifiers
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B2020-390R
Identifier Type: -
Identifier Source: org_study_id