- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01942629
Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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. |
|
|
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. |
|
|
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. |
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0298-13ctil
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