Serous Papillary Endometrial CancerNCT01267357
P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer
An observational study of Serous Papillary Endometrial Cancer, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Serous Papillary Endometrial Cancer
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Nov 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women diagnosed with endometrial cancer, having undergone surgery and having received chemotherapy in our institution.
Who may be able to join
- diagnosis of endometrial cancer
- histology block exists in hospital's library
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of the P16 Protein in Serous Papillary Endometrial Cancer, and Its Clinical and Prognostic Significance
P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.
The current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.
following anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.
Blocks from endometrioid endometrial cancer will be used as a control group.
- Conditions
- Serous Papillary Endometrial Cancer
- Being tested
- no intervention
- Keywords
- Serous Papillary Endometrial Cancer, Endometrioid endometrial cancer, biomarkers, P16, P53, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Serous papillary endometrial ca patients | 30 patients diagnosed with SP endometrial ca Receives: Other: no intervention | |
| Endometrioid endometrial ca | 32 patients diagnosed with Endometrioid endometrial ca Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: last followup (2-10 years)
Secondary outcomes (2)
progression free survival
Measured: Current follow up (2-10 years)
correlation of P16 stain with histological diagnosis
Measured: at last follow up (2-10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serous Papillary Endometrial CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267357
- Sponsor's protocol ID
- 230CTIL
- Status last verified
- Nov 2010
- First submitted
- 15 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of the P16 Protein in Serous Papillary Endometrial Cancer, and Its Clinical and Prognostic Significance
- ClinicalTrials.gov ID
- NCT01267357
- Acronym / sponsor ID
- 230CTIL
- Conditions
- Serous Papillary Endometrial Cancer
- Keywords
- Serous Papillary Endometrial Cancer, Endometrioid endometrial cancer, biomarkers, P16, P53, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- First posted
- 28 Dec 2010 (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.
P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.
The current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.
following anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.
Blocks from endometrioid endometrial cancer will be used as a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serous papillary endometrial ca patients | – | Other: no intervention30 patients diagnosed with SP endometrial ca |
| Endometrioid endometrial ca | – | Other: no intervention32 patients diagnosed with Endometrioid endometrial ca |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women diagnosed with endometrial cancer, having undergone surgery and having received chemotherapy in our institution.
Key inclusion criteria (2 listed)
- diagnosis of endometrial cancer
- histology block exists in hospital's library
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| no intervention | Other | Endometrioid endometrial ca, Serous papillary endometrial ca patients |
Primary outcome
Overall survival
Time frame: last followup (2-10 years)
2 secondary outcomes
progression free survival
Time frame: Current follow up (2-10 years)
correlation of P16 stain with histological diagnosis
Time frame: at last follow up (2-10 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serous Papillary Endometrial Cancer, run by Rambam Health Care Campus at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: last followup (2-10 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 28 Dec 2010.