NCT06515587 Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer
| NCT ID | NCT06515587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | PDAC |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-08-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CA19-9 is an acidic glycoside containing sialic acid, called ganglioside. Lewis blood group antigen is the precursor for the synthesis of CA19-9, which is formed by the combined action of sialic acid transferase and fucosyltransferase (FUT3). The ability to produce soluble blood group substances is determined by the alpha (1,2) fucosyltransferase gene (FUT2), which can be divided into secretory Se, weakly secretory Sew, and non secretory SE. The Lewis antigen positive (Lewis+) population has normal CA19-9 secretion function, while the Lewis antigen negative (Lewis -) population (about 7%) usually shows no or low secretion of CA19-9. Therefore, when CA19-9 is used as a biomarker, the combined detection of Lewis antigen status is a marker to judge the prognosis of pancreatic cancer, which can divide pancreatic cancer patients into high/medium/low malignant phenotypes.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06515587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying PDAC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06515587 currently recruiting?
Yes, NCT06515587 is actively recruiting participants. Contact the research team at jiang.long@shgh.cn for enrollment information.
Where is the NCT06515587 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06515587 clinical trial?
NCT06515587 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 40 participants.