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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01942629
Other study ID # 0298-13ctil
Secondary ID
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


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
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