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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01942629
• Other study ID #: 0298-13ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2013
• Last updated: September 10, 2013
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Adenocarcinoma
• Breast Neoplasms
• Lung Adenocarcinoma
• Lung Neoplasms
• Pancreatic Ductal Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 year overall survival	if the patient is alive or dead 5 years following the treatment	5 years	No
Secondary	recurrence free survival	the recurrence of the disease within 5 years from the treatment	5 years	No