NCT05228808

Brief Summary

Pancreatic carcinoma is ranked the 11th most common cancer worldwide. It is a highly lethal malignant tumor. In Egypt, the disease has traditionally been considered rare, but population in the East Nile Delta region exhibits an unusually high rate of young-onset pancreatic carcinoma. Pancreatic ductal adenocarcinoma is by far the most common histologic subtype of pancreatic malignancy. Programmed death ligand-1 (PD-L1) is a type I trans-membrane glycoprotein. It has an important prognostic and predictive value in various neoplasms. To date, few studies have addressed the potential prognostic role of PD-L1 in pancreatic carcinoma, so knowledge about its prognostic value needs further elucidation.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 27, 2022

Last Update Submit

January 27, 2022

Conditions

Keywords

Pancreatic ductal adenocarcinomaPD-L1Prognostic value

Outcome Measures

Primary Outcomes (2)

  • evaluate the expression of PD-L1 in pancreatic ductal adenocarcinoma

    Immunohistochemical study

    1 month

  • correlate PD-L1 expression to different studied histopathological parameters to evaluate its prognostic value.

    Statistical analysis

    1 month

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fifty specimens of pancreatic adenocarcinoma obtained from patients who underwent surgery, according to local Ethical Committee regulations, to be examined in the Pathology Laboratory of Sohag Faculty of Medicine. From January 2022 till completing the sample size.

You may qualify if:

  • Patients with pancreatic ductal adenocarcinoma who underwent surgery.

You may not qualify if:

  • Patients received pre-operative chemotherapy or radiotherapy.
  • Patients with insufficient clinical data.
  • Specimens with extensive necrosis
  • Tiny specimens which are insufficient for accurate diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Sohag University

Sohag, Egypt

RECRUITING

Study Officials

  • Nagwa Ahmed, Lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagwa Ahmed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Pathology Department, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 8, 2022

Study Start

February 1, 2022

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations