Study of Neuroendocrine Neoplasms and Adrenocortical Carcinoma
Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC)
This study is trying to learn more about how neuroendocrine tumors and adrenocortical carcinoma behave over time by collecting samples and information from people who have these rare cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05237934 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the natural history of neuroendocrine neoplasms (NENs), including adrenocortical carcinoma (ACC), by collecting tissue samples and clinical data from participants. It focuses on understanding the patterns of disease progression and responses to various therapeutic interventions. Participants will be monitored over time to gather comprehensive data on their conditions, which will aid in improving management strategies for these rare cancers. The study includes individuals with confirmed or suspected NENs and aims to enhance knowledge about these malignancies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed or suspected neuroendocrine neoplasms or adrenocortical carcinoma.
Not a fit: Patients without a diagnosis or suspicion of neuroendocrine neoplasms or adrenocortical carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of neuroendocrine neoplasms, ultimately benefiting patients through better treatment strategies.
How similar studies have performed: Other studies have shown success in understanding neuroendocrine tumors, but this specific approach to longitudinally evaluate NENs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Age \>= 18 years old * The ability of the participant to understand and the willingness to sign a written consent document. * Participants with the documentation of: * histological or cytological confirmation of NENs or adrenocortical cancer OR --biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-hydroxyindoleacetic acid (5-HIAA)), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, Cpeptide (proinsulin), glucagon, anterior pituitary hormones OR --Suspicion of NEN (from any site/origin) on axial imaging (computed tomography (CT)/ magnetic resonance imaging (MRI) / fluorodeoxyglucose (FDG) positron emission tomography (PET) / 68Ga-Dotatate scan OR --a germline genetic variant that predisposes to NETs including ACC. EXCLUSION CRITERIA: None
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jaydira Del Rivero, M.D. — National Cancer Institute (NCI)
- Study coordinator: Anna Liza F Rivero
- Email: anna.rivero@nih.gov
- Phone: (240) 858-7946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.