Assessing Prognosis in Pancreatic Cancer Using Lewis Antigen and CA19-9 Tests
To Evaluate a Prospective, Multicenter, Exploratory Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer
NA · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · NCT06515587
This study is testing if combining Lewis antigen and CA19-9 tests can help doctors better understand the outlook for patients with pancreatic cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06515587 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the prognosis of patients with pancreatic ductal adenocarcinoma (PDAC) by combining the detection of Lewis antigens with the CA19-9 biomarker. It employs a prospective, multicenter design to classify patients based on their Lewis antigen status and CA19-9 levels, observing their survival outcomes. The study will also assess the sensitivity and specificity of Lewis antigen detection in both pancreatic cancer patients and non-cancer subjects. By analyzing the relationship between Lewis subtypes, age, and overall survival, the study seeks to enhance prognostic accuracy for pancreatic cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 years with a confirmed diagnosis of pancreatic ductal adenocarcinoma.
Not a fit: Patients with other concurrent malignancies or those unable to follow a specific anti-cancer treatment plan may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate prognostic tool for patients with pancreatic cancer, potentially guiding treatment decisions.
How similar studies have performed: While the combination of Lewis antigen and CA19-9 testing is a novel approach, similar studies have shown promise in improving prognostic assessments in cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily enrolled, regardless of gender, aged ≥ 18 and ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form; 2. ECOG 0-2 3. Pathologically confirmed as pancreatic ductal adenocarcinoma; Or confirmed by pathology and clinical examination as pancreatic ductal adenocarcinoma. 4. Willing to accept routine CA19-9 testing, Lewis antigen sample collection and testing (2-3ml), and follow-up Non pancreatic cancer subjects enrolled in this study must meet all the following criteria 1\. Voluntary enrollment, regardless of gender, age ≥ 18 years, ≤ 75 years old, and the patient can understand and is willing to sign an informed consent form 2. Willing to accept Lewis antigen sample collection and testing (2-3ml) Exclusion Criteria: 1. Suffering from the second or double primary malignant tumor besides pancreatic cancer at the same time 2. Patients with pancreatic cancer who cannot trace the specific anti-cancer treatment plan 3. HIV positive 4. Other situations that researchers believe need to be excluded
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai General Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Long Jiang, MD
- Email: jiang.long@shgh.cn
- Phone: 18017317460
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.
Conditions: PDAC