Detecting peritoneal metastasis in gastric cancer using blood tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to detect peritoneal metastasis (PM) in patients with gastric cancer through a combination of assays for cell-free DNA (cfDNA) methylation and other blood-based biomarkers. It will enroll 384 participants, collecting baseline blood samples and confirming PM diagnosis via laparoscopy with cytology. The study seeks to develop a diagnostic model for PM, addressing the limitations of current invasive procedures and imaging techniques. By utilizing non-invasive blood tests, the study hopes to improve early detection of PM in gastric cancer patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• ZhongShan Hospital, Fudan university, Shanghai, China
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yihong Sun, Ph. D — Zhongshan Hospital, Fudan University, Shanghai, China
• Study coordinator: Yihong Sun, Ph. D
• Email: sun.yihong@zs-hospital.sh.cn
• Phone: +86-021-65642662

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.