Natural History Study of Children and Adults With Adrenocortical Cancer (ACC)

NCT04447014 | Terminated

• 2 other identifiers: 20011020-C-0110
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Adrenocortical cancer (ACC) is a rare tumor. The prognosis is very poor for people with advanced stages of ACC. Some people may live with ACC for years; others live for just months. Treatment options for ACC often do not work well. Researchers want to study the clinical course of the disease. They want to understand how adrenocortical cancer appear on imaging scans, how they respond to therapies, and the best treatment for them. Objective: To gain a better understanding of adrenal cancer. Eligibility: People ages 2 and older with ACC who are enrolled in NCI protocol 19-C-0016 Design: Participants will be screened with a review of their medical records, tumor scans, and cancer test results and reports. Participants may have CT and other scans. For the scans, they will lie in a machine that takes pictures of the body. They may have blood tests. They may have a 24-hour urine collection. They may be asked to sign a new consent form for some of these tests. Participants will complete paper or electronic surveys. The surveys will ask about the effects of cancer on their emotional, physical, and behavioral well-being. Participants will receive recommendations about how to manage their issues and potential treatment options for their cancer. Participants home physician will be contacted every 6 to 12 months to collect medical information such as test results and scans. Participants may be asked to return to the NIH every 6 to 12 months for follow-up tests. Participants will contact study staff if there are any changes in their tumor. Participants will be followed on this study for life.

Conditions

Adrenocortical Carcinoma; Adrenocortical Cancer

Keywords

Clinical Outcome; Advice in the Management of Cancer; Patterns of Disease Progression; Response or Lack of Response to Therapeutic Interventions; Natural History

Outcome Measures

Primary Outcomes (1)

• Characterize the natural history of adrenocortical cancer (ACC). Data will include clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival

  Characterize the natural history of adrenocortical cancer (ACC). Data will include clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival

  10 years

Study Arms (1)

Cohort 1

Subjects with confirmed adrenocortical cancer (ACC)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary clinical

* INCLUSION CRITIERIA: * Subjects enrolled into NCI protocol 19C0016 Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors * Subjects with histologically or cytologically documented ACC. * Age greater than or equal to 2 years old * Ability of subject or parent/guardian to understand and the willingness to sign a written consent document. EXCLUSION CRITIERIA: None

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Adrenocortical Carcinoma; Adrenal Cortex Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Jaydira Del Rivero, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 25, 2020
• Study Start: June 25, 2020
• Primary Completion: June 27, 2022
• Study Completion: January 12, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (1)