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

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ClinicalTrials.gov Identifier: NCT01942629
Recruitment Status : Unknown
Verified September 2013 by SHOROOK NA'ARA MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2013
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
SHOROOK NA'ARA MD, 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.


Condition or disease Intervention/treatment
Lung Adenocarcinoma Breast Adenocarcinoma Pancreatic Ductal Adenocarcinoma Other: their will be no intervention in any of the groups, the study is retrospective

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Value of Quantitative p63 Immunostaining in Adenocarcinoma of Lung, Breast, and Pancreas
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

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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



Primary Outcome Measures :
  1. 5 year overall survival [ Time Frame: 5 years ]
    if the patient is alive or dead 5 years following the treatment


Secondary Outcome Measures :
  1. recurrence free survival [ Time Frame: 5 years ]
    the recurrence of the disease within 5 years from the treatment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 patients, 100 for each group.
Criteria

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.

Responsible Party: SHOROOK NA'ARA MD, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01942629     History of Changes
Other Study ID Numbers: 0298-13ctil
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by SHOROOK NA'ARA MD, Rambam Health Care Campus:
prognostic markers,Pancreatic ductal adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancrelipase
Gastrointestinal Agents