Clinical trial · Observational
Evaluation of Molecular Markers in Adrenal Tumors
Evaluation of Diagnostic and Prognostic Molecular Markers in Adrenal Neoplasm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow/insufficient accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Gland Neoplasms | Adrenal Gland Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery | Procedure | — | UNRESOLVED |
| Tumor tissue biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adrenal Gland Neoplasm
- description
- 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.
- interventionNames
- Procedure: Tumor tissue biopsy
- Procedure: Surgery
Primary outcomes (2)
- measure
- Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples
- timeFrame
- 5 years
- 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.
- measure
- Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
* INCLUSION CRITERIA: 1. An individual with a primary localized adrenal neoplasm greater than 2 cm in size 2. Age greater than or equal to 18 years 3. Adults must be able to understand and sign the informed consent document 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2. 5. 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. EXCLUSION CRITERIA: 1. Biochemically proven Pheochromocytoma 2. Women who are pregnant because of the possible side effects of radiation from computed tomography (CT)-guided biopsies to the unborn child.
References
Publications (3)
- BACKGROUNDKloos 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. PMID 8521790
- BACKGROUNDNIH 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. PMID 14768652
- RESULTToniato 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. PMID 18626702