Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study
NCT ID: NCT05347524
Last Updated: 2022-04-26
Study Results
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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RECRUITING
384 participants
OBSERVATIONAL
2022-03-01
2030-06-30
Brief Summary
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Detailed Description
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Laparoscopy with cytology is performed to evaluate for peritoneal spread when considering chemoradiation or surgery. However, the laparoscopy is invasive and the sensitivity of computed tomography (CT) scan is poor for detecting PM. Therefore, it is necessary to evaluate the feasibility of cfDNA methylation and other blood-based biomarkers for the PM diagnosis.
The study will enroll 384 participants with gastric cancer. Baseline blood and diagnosis of PM by laparoscopy with cytology will be collected. Participants with PM will be defined as the case arm and participants without PM will be defined as the control arm. A PM diagnostic model will be developed.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Case arm - Gastric cancer with peritoneal metastasis
Baseline blood samples will be collected from gastric cancer participants with peritoneal metastasis.
Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses
Control arm - Gastric cancer without peritoneal metastasis
Baseline blood samples will be collected from gastric cancer participants without peritoneal metastasis.
Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses
Interventions
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Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses
Eligibility Criteria
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Inclusion Criteria
2. Able to provide a written informed consent.
3. 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.
4. Diagnosis of peritoneal metastasis by laparoscopy with cytology.
1. Age 18-74 years at the day of consenting to the study.
2. Able to provide a written informed consent.
3. 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.
4. No peritoneal metastasis detected by laparoscopy with cytology.
Exclusion Criteria
2. During pregnancy or lactation.
3. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
4. Recipient of blood transfusion within 7 days prior to blood draw.
5. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
6. With other known malignant tumors or multiple primary tumors.
1. Insufficient qualified blood samples.
2. During pregnancy or lactation.
3. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
4. Recipient of blood transfusion within 7 days prior to blood draw.
5. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
6. With other known malignant tumors or multiple primary tumors.
18 Years
74 Years
ALL
No
Sponsors
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Guangzhou Burning Rock Bioengineering Ltd.
INDUSTRY
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Yihong Sun, Ph. D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai, China
Xuefei Wang, Ph. D
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai, China
Locations
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ZhongShan Hospital, Fudan university, Shanghai, China
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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B2022-081R
Identifier Type: -
Identifier Source: org_study_id
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