Using EUS to analyze circulating tumor DNA in gastrointestinal cancer patients
Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
This study is testing if a new way to collect and analyze tumor DNA from the blood of patients with gastrointestinal cancers can help doctors better stage the cancer and monitor for any return after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04782557 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize endoscopic ultrasound (EUS) to perform portal vein and hepatic vein aspiration in patients with gastrointestinal cancers. By analyzing the concentration of circulating tumor DNA (ctDNA) in these veins and peripheral blood, the researchers hope to understand the liver's first pass effect in these patients. The study will explore the potential of ctDNA as a biomarker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for cancer recurrence. This minimally invasive approach could enhance genomic diagnostics for GI cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed stage II-IV distal gastric, pancreatic, or colorectal cancer undergoing specific treatments.
Not a fit: Patients with synchronous cancers, certain tumor locations, coagulopathy, liver cirrhosis, or those unwilling to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive method for monitoring and staging gastrointestinal cancers, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA for cancer diagnostics, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria:
1. Age \>= 18 years old
2. Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
3. Undergoing treatment with either:
1. Surgery
2. Neoadjuvant chemotherapy
3. Neoadjuvant chemoirradiation
4. Palliative chemotherapy/ immunotherapy
Exclusion criteria:
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1. Synchronous cancer of other sites
2. Cardia, high lesser curve tumors, oesophagogastric junction tumors
3. Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
4. Patients with coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL
5. Patients unwilling to undergo follow-up assessments
6. Patients with liver cirrhosis, portal hypertension and/ or gastric varices
7. Patient refusal to participate
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Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Shannon Chan, FRCSEd
- Email: shannonchan@surgery.cuhk.edu.hk
- Phone: 852-35052627
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.