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Trial record 3 of 77033 for:    Neoplasms

Evaluation of Molecular Markers in Adrenal Tumors

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ClinicalTrials.gov Identifier: NCT01348698
Recruitment Status : Terminated (Slow/insufficient accrual)
First Posted : May 5, 2011
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC)

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Adrenal Gland Neoplasms
Interventions Procedure: Tumor tissue biopsy
Procedure: Surgery
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 74
Completed 2
Not Completed 72
Reason Not Completed
Does not meet lesion size criteria             1
Death             3
PI decision to close study             68
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description 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 Number of Baseline Participants 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
<=18 years
0
   0.0%
Between 18 and 65 years
60
  81.1%
>=65 years
14
  18.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants
54.33  (12.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
56
  75.7%
Male
18
  24.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Hispanic or Latino
11
  14.9%
Not Hispanic or Latino
62
  83.8%
Unknown or Not Reported
1
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   4.1%
Native Hawaiian or Other Pacific Islander
1
   1.4%
Black or African American
17
  23.0%
White
47
  63.5%
More than one race
0
   0.0%
Unknown or Not Reported
6
   8.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 74 participants
74
 100.0%
1.Primary Outcome
Title Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
Hide Description 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.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples
Hide Description 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.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma
Hide Description Gene expression levels were to be analyzed relative to disease free and overall survival in patients with adrenocortical carcinoma.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description 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.
Time Frame Date treatment consent signed to date off study, approximately 6 years and 58 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description:
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 Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.1%
Time Frame Date treatment consent signed to date off study, approximately 6 years and 58 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adrenal Gland Neoplasm
Hide Arm/Group Description 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.
All-Cause Mortality
Adrenal Gland Neoplasm
Affected / at Risk (%)
Total   3/74 (4.05%)    
Show Serious Adverse Events Hide Serious Adverse Events
Adrenal Gland Neoplasm
Affected / at Risk (%) # Events
Total   3/74 (4.05%)    
General disorders   
Death  1  3/74 (4.05%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adrenal Gland Neoplasm
Affected / at Risk (%) # Events
Total   0/74 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Naris Nilubol
Organization: National Cancer Institute
Phone: 301-451-2355
Responsible Party: Naris Nilubol, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01348698     History of Changes
Other Study ID Numbers: 110149
11-C-0149
First Submitted: May 4, 2011
First Posted: May 5, 2011
Results First Submitted: August 6, 2018
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018