An observational study in Adrenal Gland Neoplasms, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-11-26.
Sponsored by National Cancer Institute (NCI) · Observational
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(pheochromocytoma).
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9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 74 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
An individual with a primary localized adrenal neoplasm greater than 2 cm in size
EXCLUSION CRITERIA:
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.
Procedure: Tumor tissue biopsy · Procedure: Surgery
Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the 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.
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.
Time frame: 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.
Time frame: 5 years
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.
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)
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
| Milestone | Adrenal Gland Neoplasm |
|---|---|
| Started | 74 |
| Completed | 2 |
| Not completed | 72 |
| Withdrew: Does not meet lesion size criteria | 1 |
| Withdrew: Death | 3 |
| Withdrew: Pi decision to close study | 68 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Gene expression levels were to be analyzed relative to disease free and overall survival in patients with adrenocortical carcinoma.
No measurements were reported for this outcome.
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.
| Participants | Adrenal Gland Neoplasm |
|---|---|
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | 3 |
Collected over Date treatment consent signed to date off study, approximately 6 years and 58 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adrenal Gland Neoplasm | 3/74 (4.1%) | 3/74 (4.1%) | 0/74 (0%) |
| Event | Adrenal Gland Neoplasm |
|---|---|
| DeathGeneral disorders | 3/74 |
| Age, Categorical(Participants) | Adrenal Gland Neoplasm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 60 |
| >=65 years | 14 |
| Age, Continuous(years) | Adrenal Gland Neoplasm |
|---|---|
| Mean | 54.33 ± 12.58 |
| Sex: Female, Male(Participants) | Adrenal Gland Neoplasm |
|---|---|
| Female | 56 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | Adrenal Gland Neoplasm |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 62 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Adrenal Gland Neoplasm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 17 |
| White | 47 |
| More than one race | 0 |
| Unknown or Not Reported | 6 |
| Region of Enrollment(Participants) | Adrenal Gland Neoplasm |
|---|---|
| United States | 74 |
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National Cancer Institute (NCI)