Status:
RECRUITING
Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Guangzhou Burning Rock Bioengineering Ltd.
Conditions:
Cancer
Eligibility:
All Genders
18-74 years
Brief Summary
This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-bas...
Detailed Description
Peritoneal metastasis (PM) in gastric cancer is associated with a poor prognosis. Laparoscopy with cytology is performed to evaluate for peritoneal spread when considering chemoradiation or surgery. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Case Arm Participants:
- Age 18-74 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 gastric 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.
- Diagnosis of peritoneal metastasis by laparoscopy with cytology.
- Inclusion Criteria for Control Arm Participants:
- Age 18-74 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 gastric 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.
- No peritoneal metastasis detected by laparoscopy with cytology.
Exclusion
- Exclusion Criteria for All 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.
- Exclusion Criteria for Control 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT05347524
Start Date
March 1 2022
End Date
June 30 2030
Last Update
April 26 2022
Active Locations (1)
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1
ZhongShan Hospital, Fudan university, Shanghai, China
Shanghai, Shanghai Municipality, China, 200032