Lung AdenocarcinomaNCT01942629
Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas
An observational study of Lung Adenocarcinoma and Breast Adenocarcinoma, run by Rambam Health Care Campus.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma, Breast Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 patients, 100 for each group.
Who may be able to join
- Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
- Available histopathological diagnosis of the malignancy.
Who cannot join
- Patients with inoperable tumors.
- Patients with second primary tumor.
- Patients with pathological blocks not enough for future slicing.
About this study
Official title: 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.
- Being tested
- their will be no intervention in any of the groups, the study is retrospective
- Keywords
- prognostic markers,Pancreatic ductal adenocarcinoma
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
their will be no intervention in any of the groups, the study is retrospectiveOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: their will be no intervention in any of the groups, the study is retrospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year overall survival
if the patient is alive or dead 5 years following the treatment
Measured: 5 years
Secondary outcomes (1)
recurrence free survival
the recurrence of the disease within 5 years from the treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHOROOK NA'ARA MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942629
- Sponsor's protocol ID
- 0298-13ctil
- Status last verified
- Sep 2013
- First submitted
- 22 Aug 2013
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Quantitative p63 Immunostaining in Adenocarcinoma of Lung, Breast, and Pancreas
- ClinicalTrials.gov ID
- NCT01942629
- Acronym / sponsor ID
- 0298-13ctil
- Keywords
- prognostic markers,Pancreatic ductal adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung adenocarcinoma | – | Other: their will be no intervention in any of the groups, the study is retrospectiveThis 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 | – | Other: their will be no intervention in any of the groups, the study is retrospectiveThis 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 | – | Other: their will be no intervention in any of the groups, the study is retrospectiveThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients, 100 for each group.
Key inclusion criteria (2 listed)
- Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
- Available histopathological diagnosis of the malignancy.
Key exclusion criteria (3 listed)
- Patients with inoperable tumors.
- Patients with second primary tumor.
- Patients with pathological blocks not enough for future slicing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| their will be no intervention in any of the groups, the study is retrospective | Other | Breast adenocarcinoma, Lung adenocarcinoma, Pancreatic ductal adenocarcinoma |
Primary outcome
5 year overall survival
Time frame: 5 years
if the patient is alive or dead 5 years following the treatment
1 secondary outcome
recurrence free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma and Breast Adenocarcinoma, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.