Adrenal Gland NeoplasmsNCT01348698

Evaluation of Molecular Markers in Adrenal Tumors

An observational study of Adrenal Gland Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Background: Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are no tests that can accurately tell which adrenal tumors are cancerous and which are not. The only way to tell is to remove the tumor with surgery and then examine it. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Adrenal Gland Neoplasms
What is being tested?: Tumor tissue biopsy and Surgery
Type of treatment: Surgery or procedure
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 4 May 2011to 12 Jan 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous. An individual with an adrenal neoplasm greater than 2cm in size.

Who may be able to join

An individual with a primary localized adrenal neoplasm greater than 2 cm in size
Age greater than or equal to 18 years
Adults must be able to understand and sign the informed consent document
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery Note: patients with suspected but unconfirmed adrenal neoplasm may be enrolled.

Who cannot join

Biochemically proven Pheochromocytoma
Women who are pregnant because of the possible side effects of radiation from computed tomography (CT)-guided biopsies to the unborn child.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm

Background:

Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are no tests that can accurately tell which adrenal tumors are cancerous and which are not. The only way to tell is to remove the tumor with surgery and then examine it. Researchers have been using new methods to study samples of adrenal tissue. These methods may help identify whether the cells are or may become cancerous without an operation. This information will help doctors determine which tumors will need to be removed.

Objectives:

To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells.

Eligibility:

Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous.

Design:

Participants will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
Participants will be examined to determine whether they have a specific type of adrenal tumor (pheochromocytoma).
Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for study.
Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.
Researchers will examine the collected tissue. They will try to determine whether the cells are cancerous or may become cancerous.
Participants will be asked to return to the National Institutes of Health Clinical Center every year for about 5 years. During these visits they will have imaging studies, lab tests, and a physical examination.

Read the detailed description

Background:

Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies.
The majority of adrenal incidentalomas are cortical adenoma.
Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis.
There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
This protocol is designed to determine the feasibility and accuracy of using novel molecular markers of malignant adrenal neoplasm in fine needle aspiration (FNA) biopsy and surgically resected samples.

Objectives:

Primary Objectives:
To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy samples.
To determine the accuracy of novel diagnostic molecular markers in clinical adrenal FNA biopsy and surgically resected samples.
Secondary Objectives:
To analyze the gene expression level relative to disease-free survival and overall survival in patients with adrenocortical carcinoma

Eligibility:

An individual with an adrenal neoplasm greater than 2cm in size
Age greater than or equal to 18 years
Adults must be able to understand and sign the informed consent document

Design:

Prospective observational study.
Demographic, clinical, laboratory and pathologic data will be collected for each patient participant. Data will be securely stored in a computerized database.
Patients will have biochemical testing to determine if their adrenal neoplasm is functioning or nonfunctioning.
After their initial on-study evaluation, patients who are found to have a nonfunctioning adrenal tumor with a low risk of malignancy will be re-screened every year for 5 years with non-invasive imaging studies.
Treatment of patients with an adrenal neoplasm will be performed based on standard clinical practice.
Projected accrual will be 50 patients per year for a total of 10 years. Thus, we anticipate accruing 500 patients on this protocol.

Conditions: Adrenal Gland Neoplasms
Being tested: Tumor tissue biopsy, Surgery
Keywords: Adrenal Cancer, Pheochromocytoma, Functioning Tumor, Nonfunctioning Tumor, Gene Expression, Adrenal Tumor
Medical subject headings: Adrenal Gland Neoplasms, Pheochromocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tumor tissue biopsyProcedure or surgery
Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the study.
SurgeryProcedure or surgery
Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.

Study groups in NCT01348698
Study group	Role	What they receive
Adrenal Gland Neoplasm		To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells. Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Receives: Procedure: Tumor tissue biopsy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
Feasibility of molecular testing in adrenal neoplasm fine needle aspiration (FNA) samples was determined by immunohistochemistry. Ribonucleic acid and deoxyribonucleic acid was extracted from fine needle aspiration and tumor tissue samples to differentiate between normal and abnormal tissue.
Measured: 5 years
Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples
Tumor tissue obtained via FNA and surgical resection were to be analyzed for molecular markers to help determine if cells were cancerous or may become cancerous.
Measured: 5 years

Secondary outcomes (2)

To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma
Gene expression levels were to be analyzed relative to disease free and overall survival in patients with adrenocortical carcinoma.
Measured: 5 years
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Date treatment consent signed to date off study, approximately 6 years and 58 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 201112 Jan 2018

First posted5 May 2011 (estimated)
Study start4 May 2011
Primary completion12 Jan 2018
Study completion12 Jan 2018

Why it stopped: Slow/insufficient accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Adrenal Gland NeoplasmsStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
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: Prospective
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01348698
Sponsor's protocol ID: 110149
Other IDs: 11-C-0149
Status last verified: Oct 2018
First submitted: 4 May 2011
Last updated: 26 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kloos RT, Gross MD, Francis IR, Korobkin M, Shapiro B. Incidentally discovered adrenal masses. Endocr Rev. 1995 Aug;16(4):460-84. doi: 10.1210/edrv-16-4-460.
PubMed 8521790
NIH state-of-the-science statement on management of the clinically inapparent adrenal mass ("incidentaloma"). NIH Consens State Sci Statements. 2002 Feb 4-6;19(2):1-25.
PubMed 14768652
Toniato A, Boschin I, Bernante P, Foletto M, Guolo AM, Pelizzo MR, Opocher G, Ballotta E, Mantero F. Factors influencing the rising rates of adrenal surgery: analysis of a 25-year experience. Surg Endosc. 2009 Mar;23(3):503-7. doi: 10.1007/s00464-008-0061-3. Epub 2008 Jul 15.
PubMed 18626702

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adrenal Gland Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
ClinicalTrials.gov ID: NCT01348698
Acronym / sponsor ID: 110149
Conditions: Adrenal Gland Neoplasms
Keywords: Adrenal Cancer, Pheochromocytoma, Functioning Tumor, Nonfunctioning Tumor, Gene Expression, Adrenal Tumor
Study type: Observational
Recruitment status: TerminatedReason stopped: Slow/insufficient accrual
Enrolment: 74 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 4 May 2011 (actual)
Primary completion: 12 Jan 2018 (actual)
Study completion: 12 Jan 2018 (actual)
First posted: 5 May 2011 (estimated)
Results: Posted 26 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

Tumors of the adrenal gland are common. Most of them are not cancerous. However, there are no tests that can accurately tell which adrenal tumors are cancerous and which are not. The only way to tell is to remove the tumor with surgery and then examine it. Researchers have been using new methods to study samples of adrenal tissue. These methods may help identify whether the cells are or may become cancerous without an operation. This information will help doctors determine which tumors will need to be removed.

Objectives:

To collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells.

Eligibility:

Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous.

Design:

Participants will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
Participants will be examined to determine whether they have a specific type of adrenal tumor (pheochromocytoma).
Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for study.
Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.
Researchers will examine the collected tissue. They will try to determine whether the cells are cancerous or may become cancerous.
Participants will be asked to return to the National Institutes of Health Clinical Center every year for about 5 years. During these visits they will have imaging studies, lab tests, and a physical examination.

Detailed description

Background:

Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies.
The majority of adrenal incidentalomas are cortical adenoma.
Many patients with nonfunctioning adrenal incidentalomas undergo adrenalectomy to exclude a cancer diagnosis.
There are no reliable clinical, radiographic or laboratory studies that accurately distinguish between localized benign and malignant adrenal neoplasm.
This protocol is designed to determine the feasibility and accuracy of using novel molecular markers of malignant adrenal neoplasm in fine needle aspiration (FNA) biopsy and surgically resected samples.

Objectives:

Primary Objectives:
To evaluate the feasibility of molecular testing in adrenal neoplasm FNA biopsy samples.
To determine the accuracy of novel diagnostic molecular markers in clinical adrenal FNA biopsy and surgically resected samples.
Secondary Objectives:
To analyze the gene expression level relative to disease-free survival and overall survival in patients with adrenocortical carcinoma

Eligibility:

An individual with an adrenal neoplasm greater than 2cm in size
Age greater than or equal to 18 years
Adults must be able to understand and sign the informed consent document

Design:

Prospective observational study.
Demographic, clinical, laboratory and pathologic data will be collected for each patient participant. Data will be securely stored in a computerized database.
Patients will have biochemical testing to determine if their adrenal neoplasm is functioning or nonfunctioning.
After their initial on-study evaluation, patients who are found to have a nonfunctioning adrenal tumor with a low risk of malignancy will be re-screened every year for 5 years with non-invasive imaging studies.
Treatment of patients with an adrenal neoplasm will be performed based on standard clinical practice.
Projected accrual will be 50 patients per year for a total of 10 years. Thus, we anticipate accruing 500 patients on this protocol.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Adrenal Gland Neoplasm	–	Procedure: Tumor tissue biopsy, Procedure: SurgeryTo collect adrenal tumor tissue biopsy samples in order to study and evaluate new methods that may help identify cancerous or precancerous cells. Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Individuals at least 18 years of age who have an adrenal tumor that may or may not be cancerous. An individual with an adrenal neoplasm greater than 2cm in size.

Key inclusion criteria (5 listed)

Key exclusion criteria (2 listed)

Biochemically proven Pheochromocytoma
Women who are pregnant because of the possible side effects of radiation from computed tomography (CT)-guided biopsies to the unborn child.

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
Tumor tissue biopsyParticipants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the study.	Procedure or surgery	Adrenal Gland Neoplasm
SurgeryParticipants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.	Procedure or surgery	Adrenal Gland Neoplasm

Primary outcome

Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
Time frame: 5 years
Feasibility of molecular testing in adrenal neoplasm fine needle aspiration (FNA) samples was determined by immunohistochemistry. Ribonucleic acid and deoxyribonucleic acid was extracted from fine needle aspiration and tumor tissue samples to differentiate between normal and abnormal tissue.
Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples
Time frame: 5 years
Tumor tissue obtained via FNA and surgical resection were to be analyzed for molecular markers to help determine if cells were cancerous or may become cancerous.

2 secondary outcomes

To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma
Time frame: 5 years
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Time frame: Date treatment consent signed to date off study, approximately 6 years and 58 days

Results and safety

Results posted to the registry on 26 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adrenal Gland Neoplasm	74	2

Primary outcome: Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples

Time frame: 5 years

Population analysed: Because the study was terminated due to poor accrual and all fine needle aspiration (FNA) samples were benign, molecular testing cannot be performed in the absence of cancerous tumors. Molecular testing was not done in any samples collected.

Primary outcome: Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples

Time frame: 5 years

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Date treatment consent signed to date off study, approximately 6 years and 58 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adrenal Gland Neoplasm	3 of 74 (4.1%)	0 of 74 (0%)	3 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8521790Kloos RT, Gross MD, Francis IR, Korobkin M, Shapiro B. Incidentally discovered adrenal masses. Endocr Rev. 1995 Aug;16(4):460-84. doi: 10.1210/edrv-16-4-460.
Background: PubMed 14768652NIH state-of-the-science statement on management of the clinically inapparent adrenal mass ("incidentaloma"). NIH Consens State Sci Statements. 2002 Feb 4-6;19(2):1-25.
Results publication: PubMed 18626702Toniato A, Boschin I, Bernante P, Foletto M, Guolo AM, Pelizzo MR, Opocher G, Ballotta E, Mantero F. Factors influencing the rising rates of adrenal surgery: analysis of a 25-year experience. Surg Endosc. 2009 Mar;23(3):503-7. doi: 10.1007/s00464-008-0061-3. Epub 2008 Jul 15.
Individual participant dataSharing planned: No

Related trials for Adrenal Gland Neoplasms

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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.

Naris Nilubol, M.D. principal investigator

National Cancer Institute (NCI)

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 Adrenal Gland Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Nov 2018. 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 United States. 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?

Yes. Results are posted in the registry (first posted 26 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01348698, which also lists 3 linked publications.

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 26 Nov 2018.