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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
SHOROOK NA'ARA MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01942629
First received: August 22, 2013
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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 Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Value of Quantitative p63 Immunostaining in Adenocarcinoma of Lung, Breast, and Pancreas

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 5 year overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    if the patient is alive or dead 5 years following the treatment


Secondary Outcome Measures:
  • recurrence free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    the recurrence of the disease within 5 years from the treatment


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: SHOROOK NA'ARA MD, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01942629     History of Changes
Other Study ID Numbers: 0298-13ctil
Study First Received: August 22, 2013
Last Updated: September 10, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
prognostic markers,Pancreatic ductal adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Carcinoma, Ductal, Breast
Lung Neoplasms
Breast Diseases
Carcinoma
Carcinoma, Ductal
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014