Expression and Clinical Significance of IGHD in Pancreatic Cancer

Gene Expression Clinical Trial

Official title:

Expression and Clinical Significance of IGHD in Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327400
• Other study ID #: NTlyh76
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2022
• Source: Affiliated Hospital of Nantong University
• Contact: Lu Y Yuhua, phd
• Phone: +86 13862815432
• Email: lyh76[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background ： Pancreatic cancer is the most malignant tumor in the digestive system, with low level of early diagnosis and poor prognosis. There is a lack of high sensitive and specific molecular markers in the diagnosis, treatment and prognosis of pancreatic cancer.

Objective： To explore the expression of IGHD in pancreatic cancer and its correlation with clinical parameters, and to explore its prognostic value in patients with pancreatic cancer.

Methods： In this study, qRT-PCR was used to detect IGHD expression in peripheral blood. The expression of IGHD in pancreatic cancer and healthy individuals was compared. The PCR results were combined with clinical data of patients. To compare the expression of IGHD in different pancreatic cancer stages and evaluate whether IGHD expression in peripheral blood can be a potential biomarker for the diagnosis of pancreatic cancer, chi-square test was used to analyze the factors influencing the expression level of IGHD. Kaplan-Meier was used to analyze patient prognosis, and further Cox regression analysis was used to analyze the factors influencing patient prognosis and independent risk factors.

Description:

Methods：The expressions of IGHD in peripheral blood of about 30 patients with pancreatic cancer and more than 30 healthy controls were detected by qRT-PCR, and the differences of IGHD were analyzed.The expression of IGHD in pancreatic cancer and healthy individuals was compared. The PCR results were combined with clinical data of patients. To compare the expression of IGHD in different pancreatic cancer stages and evaluate whether IGHD expression in peripheral blood can be a potential biomarker for the diagnosis of pancreatic cancer, chi-square test was used to analyze the factors influencing the expression level of IGHD. Kaplan-Meier was used to analyze patient prognosis, and further Cox regression analysis was used to analyze the factors influencing patient prognosis and independent risk factors.

Pancreatic cancer is a disease of digestive system with a high degree of malignancy. The level of early diagnosis and therapeutic effect are limited by the research status of pancreatic adenocarcinoma. Conventional CT, MRI and other methods have a limited level of early diagnosis of pancreatic cancer, and EUS and endoscope-guided needle biopsy are in the stage of clinical trials. Studies on novel markers involve protein, miRNA, exosome, methylation, protein and genomics, but there is no mature and practical diagnostic method. Based on the current diagnosis, treatment and prognosis level of pancreatic cancer, I made a bold attempt to study the expression of IGHD in pancreatic cancer and their relationship with clinical parameters and prognosis level, so as to screen molecular markers conducive to diagnosis, treatment and prognosis of pancreatic cancer and provide data support for improving the diagnosis and treatment level of pancreatic cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with pathologically confirmed pancreatic cancer

Exclusion Criteria:

• noperable patients

• other malignant tumors

Related Conditions & MeSH terms

• Gene Expression
• Pancreatic Neoplasms

Intervention

Other:
• Pathological
The pancreatic cancer cohort and the healthy cancer-free patient cohort were divided according to pathology reports

Locations

Country	Name	City	State
China	The Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High expression of IGHD is independent risk factors for poor prognosis in patients with pancreatic cancer.	IGHD was highly expressed in pancreatic cancer patients , but low in the healthy cancer-free patients.; Patients with high expression of IGHD had lower prognosis. High expression of IGHD, T stage (T3T4), lymphatic metastasis and distant metastasis are independent risk factors for poor prognosis in patients with pancreatic cancer.; Expression level of IGHD in peripheral blood cells is a potential biomarker for the diagnosis of pancreatic cancer	2022.4-2023.10