NCT05327400

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

September 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

April 7, 2022

Last Update Submit

September 2, 2022

Conditions

Keywords

Pancreatic CancerClinical SignificanceexpressionprognosisIGHD

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

pancreatic cancer patients

pathologically confirmed pancreatic cancer patients

Other: Pathological

healthy people

people without no neoplastic lesions and other organic diseases

Interventions

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

pancreatic cancer patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with operable pancreatic cancer without other malignancies

You may qualify if:

  • Patients with pathologically confirmed pancreatic cancer

You may not qualify if:

  • noperable patients
  • other malignant tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood from pancreatic cancer patients and healthy cancer-free patients

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Lu Y Yuhua, phd

    The Affiliated Hospital of Nantong University

    STUDY DIRECTOR
  • Chen Q Qiyang, master

    Nantong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Y Yuhua, phd

CONTACT

Chen Q QiYang, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

May 1, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

September 6, 2022

Record last verified: 2022-03

Locations