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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347524
• Other study ID #: B2022-081R
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: June 30, 2030

Study information

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

Clinical Trial 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-based biomarkers. The study will enroll 384 participants with gastric cancer.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: June 30, 2030
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria for Case Arm Participants:

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. Diagnosis of peritoneal metastasis by laparoscopy with cytology.

• Inclusion Criteria for Control Arm Participants:

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:

• Exclusion Criteria for All Participants:

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.

• Exclusion Criteria for Control Arm Participants:

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis

Intervention

Other:
• Baseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses

Locations

Country	Name	City	State
China	ZhongShan Hospital, Fudan university, Shanghai, China	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Guangzhou Burning Rock Bioengineering Ltd

Country where clinical trial is conducted

China, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer.		30 months
Primary	Sensitivity and specificity of a cfDNA methylation-based model, in combination with other biomarkers, for detecting peritoneal metastasis of gastric cancer.		30 months