Detecting peritoneal metastasis in gastric cancer using blood tests
Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study
This study is testing whether blood tests can help find peritoneal metastasis in people with gastric cancer more easily than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 384 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05347524 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-74 with a recent diagnosis of gastric cancer and no prior cancer treatment.
Not a fit: Patients with prior cancer treatment or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accurate method for diagnosing peritoneal metastasis in gastric cancer patients.
How similar studies have performed: Other studies have shown promise in using liquid biopsy techniques for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.