Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

• Conditions: Lung Adenocarcinoma; Breast Adenocarcinoma; Pancreatic Ductal Adenocarcinoma
• Interventions: Other: their will be no intervention in any of the groups, the study is retrospective

• Registration Number: NCT01942629
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.

Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.

In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-22
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-10
• Last Update Submitted: 2013-09-10
• Study First Posted: 2013-09-16
• Last Update Posted: 2013-09-16
• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
• Available histopathological diagnosis of the malignancy.

Exclusion Criteria

• Patients with inoperable tumors.
• Patients with second primary tumor.
• Patients with pathological blocks not enough for future slicing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung adenocarcinoma	their will be no intervention in any of the groups, the study is retrospective	This group will include 100 patients with lung adenocarcinoma, the clinical outcomes will be retrospectively assessed. at the same time 2 histopathological slides will be retrieved and stained for known markers as well as to P63.
Breast adenocarcinoma	their will be no intervention in any of the groups, the study is retrospective	This group will include 100 patients with breast adenocarcinoma, the clinical outcomes will be retrospectively assessed. at the same time 2 histopathological slides will be retrieved and stained for known markers as well as to P63.
Pancreatic ductal adenocarcinoma	their will be no intervention in any of the groups, the study is retrospective	This group will include 100 patients with pancreatic ductal adenocarcinoma, the clinical outcomes will be retrospectively assessed. at the same time 2 histopathological slides will be retrieved and stained for known markers as well as to P63.

Primary Outcome Measures

Name	Time	Method
5 year overall survival	5 years	if the patient is alive or dead 5 years following the treatment

Secondary Outcome Measures

Name	Time	Method
recurrence free survival	5 years	the recurrence of the disease within 5 years from the treatment