Adrenal Cortex NeoplasmsNCT02747355
Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
An observational study of Adrenal Cortex Neoplasms and Adrenal Cortex Diseases, run by Bnai Zion Medical Center.
Trial summary
In adrenal tumors, the investigators will examine if there is any correlation between WIESS criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Cortex Neoplasms, Adrenal Cortex Diseases
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2016to Dec 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adrenal tissue from patients diagnosed with adrenocortical carcinoma, adrenal adenoma and normal adrenals from patients who had renal and adrenal excision for renal cancer
Who may be able to join
- adrenal carcinoma
- adrenal adenoma
- normal adrenal tissue
Who cannot join
- NA
About this study
In adrenal tumors, the investigators will examine if there is any correlation between WIESS criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A.
Read the detailed description
One of the problems in managing adrenocortical tumors is the ability to distinguish between benign and malignant tumors, while needle biopsy is unable to distinguish between the two situations. Therefore, when imaging tests demonstrate a suspected malignant adrenal tumor, surgical excision of the tumor is needed. Usually, the histological WIESS criteria are used in order to determine malignancy. However, there are cases when adrenal tumors were defined by WIESS criteria as benign but metastasized later. Moreover, there is no reliable test than can determine prognosis. KI-67 labeling index is a proliferation biomarker which is used to tell more about the malignant potential and prognosis of adrenal carcinoma.
In various types of tumors, proliferation biomarkers are used in attempt to tell about prognosis. In this study, the investigators will examine whether some biomarkers can differentiate between adrenal carcinoma and adenoma and if the degree of expression of these markers is correlated with prognosis.
The investigators will retrospectively collect 30 cases of adrenal carcinoma, 30 cases of adrenal adenoma and 10 cases of normal adrenals. All specimens are preserved with formalin. The investigators will re-review the WIESS criteria and all samples will be analyzed for the index labeling of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A. The investigators will examine if there is any correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.
- Conditions
- Adrenal Cortex Neoplasms, Adrenal Cortex Diseases
- Medical subject headings
- Adrenal Cortex Neoplasms, Adrenal Cortex Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
MCM3 expression
Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
MCM2 expression
Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
P53 expression
Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
NEUROPILIN -1 expression
Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
METALLOTHIONEIN expression
Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
SEMAPHORIN-3A expression
Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
E-caderein expression
Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
Secondary outcomes (2)
KI67
Difference in Ki67 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
Measured: 1 year
Prognosis
Correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start18 Aug 2016
- Primary completion1 Jul 2018
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Cortex NeoplasmsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, leonard.saiegh, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747355
- Sponsor's protocol ID
- BnaiZion
- Status last verified
- Jan 2019
- First submitted
- 19 Apr 2016
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Different Proliferation Biomarkers in Adreno-cortical Tumors
- ClinicalTrials.gov ID
- NCT02747355
- Acronym / sponsor ID
- BnaiZion
- Conditions
- Adrenal Cortex Neoplasms, Adrenal Cortex Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Apr 2016 (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.
In adrenal tumors, the investigators will examine if there is any correlation between WIESS criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A.
Detailed description
One of the problems in managing adrenocortical tumors is the ability to distinguish between benign and malignant tumors, while needle biopsy is unable to distinguish between the two situations. Therefore, when imaging tests demonstrate a suspected malignant adrenal tumor, surgical excision of the tumor is needed. Usually, the histological WIESS criteria are used in order to determine malignancy. However, there are cases when adrenal tumors were defined by WIESS criteria as benign but metastasized later. Moreover, there is no reliable test than can determine prognosis. KI-67 labeling index is a proliferation biomarker which is used to tell more about the malignant potential and prognosis of adrenal carcinoma.
In various types of tumors, proliferation biomarkers are used in attempt to tell about prognosis. In this study, the investigators will examine whether some biomarkers can differentiate between adrenal carcinoma and adenoma and if the degree of expression of these markers is correlated with prognosis.
The investigators will retrospectively collect 30 cases of adrenal carcinoma, 30 cases of adrenal adenoma and 10 cases of normal adrenals. All specimens are preserved with formalin. The investigators will re-review the WIESS criteria and all samples will be analyzed for the index labeling of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A. The investigators will examine if there is any correlation between the labeling index of each biomarker, WIESS criteria and prognosis of the tumor.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adrenal tissue from patients diagnosed with adrenocortical carcinoma, adrenal adenoma and normal adrenals from patients who had renal and adrenal excision for renal cancer
Key inclusion criteria (3 listed)
- adrenal carcinoma
- adrenal adenoma
- normal adrenal tissue
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MCM3 expression
Time frame: 1 year
Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
MCM2 expression
Time frame: 1 year
Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
P53 expression
Time frame: 1 year
Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
NEUROPILIN -1 expression
Time frame: 1 year
Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
METALLOTHIONEIN expression
Time frame: 1 year
Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
SEMAPHORIN-3A expression
Time frame: 1 year
Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
E-caderein expression
Time frame: 1 year
Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma
2 secondary outcomes
KI67
Time frame: 1 year
Prognosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: Yes
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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 Adrenal Cortex Neoplasms and Adrenal Cortex Diseases, run by Bnai Zion Medical Center.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2019. 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?
MCM3 expression (time frame: 1 year). The study lists 7 primary outcomes in all. 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 18 Jan 2019.