NCT06055647

Brief Summary

Pancreatic duct adenocarcinoma is a highly aggressive carcinoma that is associated with a poor prognosis. Detection of novel biological markers that are specifically over expressed in pancreatic duct adenocarcinoma and their subsequent targeting by anti cancer therapeutic modalities may improve patient's survival.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3.7 years

First QC Date

September 20, 2023

Last Update Submit

September 20, 2023

Conditions

Keywords

HER-2Pancreatic Duct AdenocarcinomaImmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • correlation of HRE-2 expression with clinical and pathological parameters

    levels of HER-2 expression will be correlated with clinical parameters (as patients' ages, sexes, tumor location), and pathological parameters (as tumor grades, stages, neural and vascular invasion).

    6 months

Interventions

Formalin-fixed, Paraffin-embedded tissue blocks of pancreatic duct adenocarcinoma will be stained by anti HER-2, by immunohistochemical approach.

Eligibility Criteria

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

• This study will be performed on archived formalin-fixed, paraffin-embedded tissue blocks that belonged to 37 patients who were admitted to Assuit and Sohag Oncology Centers and Sohag university hospital from January, 1st, 2017 to December, 31st, 2020. Patients' complaints included obstructive jaundice, abdominal pain and vomiting. Radiological assessment revealed heterogeneous suspicious pancreatic lesions from which tru-cut biopsies were obtained and examined by the standard staining method; hematoxylin and eosin (H\&E). Cases diagnosed as pancreatic carcinoma on the basis of tru-cut biopsies underwent pancreaticoduodenectomy (Whipple procedure) or distal pancreatectomy, depending on tumor location.

You may qualify if:

  • Cases of PDAC who underwent radical operations.
  • Tissue blocks with sufficient material.
  • Cases with available clinical data.

You may not qualify if:

  • Cases of pancreatic carcinoma other than PDAC.
  • Patients who received preoperative chemotherapy or radiotherapy.
  • Patients with PDAC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
  • Cases with insufficient/destructed material.
  • Patients with inadequate clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maisa H Mohammed, MD

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

January 1, 2017

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

September 28, 2023

Record last verified: 2023-09