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

September 10, 2013 updated by: SHOROOK NA'ARA MD, Rambam Health Care Campus

Prognostic Value of Quantitative p63 Immunostaining in Adenocarcinoma of Lung, Breast, and Pancreas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

300 patients, 100 for each group.

Description

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 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
Lung adenocarcinoma

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.
Other: their will be no intervention in any of the groups, the study is retrospective
Breast adenocarcinoma

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.
Other: their will be no intervention in any of the groups, the study is retrospective
Pancreatic ductal adenocarcinoma

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.
Other: their will be no intervention in any of the groups, the study is retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 year overall survival
Time Frame: 5 years
if the patient is alive or dead 5 years following the treatment
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence free survival
Time Frame: 5 years
the recurrence of the disease within 5 years from the treatment
5 years

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

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

October 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0298-13ctil

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.

Clinical Trials on Lung Adenocarcinoma

Clinical Trials on their will be no intervention in any of the groups, the study is retrospective

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe