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RecruitingNot ApplicableNCT06515587

Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

40 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

PDAC

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether testing for a blood marker called the Lewis antigen, alongside the standard CA19-9 blood test, can better predict how pancreatic cancer will progress. Researchers want to understand if these two tests together give doctors more useful information about a patient's outlook. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with pancreatic ductal adenocarcinoma (a type of pancreatic cancer) confirmed by biopsy or clinical tests - You are well enough to carry out everyday activities (ECOG score 0–2) - You are willing to have a small blood sample (2–3 mL) taken for Lewis antigen testing and to attend follow-up visits **You may NOT be eligible if...** - You have a second, separate cancer at the same time as your pancreatic cancer - Your specific cancer treatment plan cannot be tracked or recorded - You are HIV positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTLewis genotype detection reagent

By evaluating the results of the Lewis gene test combined with the CA19-9 test, different subtypes of pancreatic cancer patients were differentiated to evaluate the prognosis

Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06515587

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