Trial Outcomes & Findings for Evaluation of Molecular Markers in Adrenal Tumors (NCT NCT01348698)

NCT ID: NCT01348698

Last Updated: 2018-11-26

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 74 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2018-11-26

Participant Flow

Participant milestones

Measure	Adrenal Gland Neoplasm Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. 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.
Overall Study STARTED	74
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	72

Reasons for withdrawal

Measure	Adrenal Gland Neoplasm Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. 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.
Overall Study Does not meet lesion size criteria	1
Overall Study Death	3
Overall Study PI decision to close study	68

Baseline Characteristics

Evaluation of Molecular Markers in Adrenal Tumors

Baseline characteristics by cohort

Measure	Adrenal Gland Neoplasm n=74 Participants Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	54.33 years STANDARD_DEVIATION 12.58 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 years

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: 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.

Gene expression levels were to be analyzed relative to disease free and overall survival in patients with adrenocortical carcinoma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 6 years and 58 days

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.

Outcome measures

Measure

Adrenal Gland Neoplasm n=74 Participants Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. 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.

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

3 Participants

Adverse Events

Adrenal Gland Neoplasm

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure

Adrenal Gland Neoplasm n=74 participants at risk Adrenal neoplasms are common and are incidentally discovered in 4-10% of abdominal imaging studies. Most adrenal tumors are not cancerous. 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.

General disorders Death

4.1% 3/74 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 years and 58 days.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Naris Nilubol

National Cancer Institute

Phone: 301-451-2355

Email: niluboln@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place