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Trial Title:
Clinical Study of Lewis Antigen Assay Combined With CA19-9 Assay to Assess Prognosis in Patients With Pancreatic Cancer
NCT ID:
NCT06515587
Condition:
PDAC
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Lewis genotype detection reagent
Description:
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
Arm group label:
Study group
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.
Detailed description:
1. This study adopts a prospective, multicenter design, and classifies pancreatic
cancer patients and predicts their prognosis through Lewis antigen detection and
CA19-9 detection.
2. Observe the survival time of pancreatic cancer subjects to observe the consistency
between Lewis typing and prognosis, and evaluate the sensitivity of Lewis antigen
detection.
3. Evaluate the specificity of Lewis antigen detection by observing the distribution of
Lewis subtypes in non pancreatic cancer subjects.
4. Explore the prognostic distribution of age, different Lewis subtypes, and overall
survival cycle for Lewis antigen detection.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Long, MD
Phone:
+86 18017317460
Email:
jiang.long@shgh.cn
Start date:
August 1, 2024
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06515587
