Expression and Clinical Significance of IGHD in Pancreatic Cancer

September 2, 2022 updated by: Affiliated Hospital of Nantong University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lu Y Yuhua, phd
  • Phone Number: China +86 13862815432
  • Email: lyh76@126.com

Study Contact Backup

  • Name: Chen Q QiYang, master
  • Phone Number: China +86 18860970651
  • Email: drcqy13@126.com

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Nantong University
        • Contact:
          • Lu Yuhua, phd
          • Phone Number: +8613862815432
          • Email: lyh76@126.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with operable pancreatic cancer without other malignancies

Description

Inclusion Criteria:

  • Patients with pathologically confirmed pancreatic cancer

Exclusion Criteria:

  • noperable patients
  • other malignant tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pancreatic cancer patients
pathologically confirmed pancreatic cancer patients
Other: Pathological
The pancreatic cancer cohort and the healthy cancer-free patient cohort were divided according to pathology reports
healthy people
people without no neoplastic lesions and other organic diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High expression of IGHD is independent risk factors for poor prognosis in patients with pancreatic cancer.
Time Frame: 2022.4-2023.10

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Study Director: Lu Y Yuhua, phd, The Affiliated Hospital of Nantong University
  • Principal Investigator: Chen Q Qiyang, master, Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTlyh76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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