Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04447014
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Adrenocortical Carcinoma Adrenocortical Cancer

Detailed Description:

Background:

  • Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per million people per year. It has a very poor prognosis with an overall 5-year mortality rate of 75-90% and an average survival from the time of diagnosis of 14.5 months. Approximately 10% of ACC cases are associated with a hereditary cancer predisposition syndrome.
  • The treatment of choice for a localized primary or recurrent tumor is surgical resection. Patients with recurrent or metastatic disease are infrequently curable by surgery alone.
  • As with most solid tumors, chemotherapy options have limited benefit, although platinumbased therapies have response rates of 25 to 30%. To date no targeted therapy has been shown to be of any value in this disease. The role of neoadjuvant and adjuvant therapies, including systemic chemotherapy and radiotherapy, remains poorly defined and has been reported to have only a modest or no therapeutic effect.
  • The natural history of ACC can vary greatly with some patients surviving only months while others can live with disease for years. The basis for these differing clinical presentations is not known. While one cannot exclude an immune or other host component as responsible for the diverse clinical courses, it is also possible that there may be a genetic basis for this phenomenon.
  • Patients with rare tumors seek expert advice in the management of their care. A natural history study would establish a more formal mechanism for such referrals, while allowing the systematic collection of epidemiologic, genomic, molecular data.

Objective:

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

Eligibility:

  • Subjects with documented ACC
  • Age greater than or equal to 2 years old.

Design:

  • This protocol is a subprotocol to protocol 19C0016 Natural History and Biospecimen Accrual Study for Children and Adults with Rare Solid Tumors . After enrollment on the master protocol and undergoing evaluations detailed in the master protocol, patients will be enrolled on this subprotocol specific for ACC.
  • Medical history will be collected from medical records and patients followed throughout the course of their illnesses, with particular attention to patterns of disease recurrence and progression, response to therapies, duration of responses and hormone production in patients with hormone production as a manifestation of their disease, and patient reported outcomes. Tumor growth rates will also be calculated throughout the course of the disease.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History Study of Children and Adults With Adrenocortical Cancer
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort 1
Subjects with confirmed adrenocortical cancer (ACC)



Primary Outcome Measures :
  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 [ Time Frame: 10 years ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary clinical
Criteria
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447014


Contacts
Layout table for location contacts
Contact: Iqra (Mehwish) Ahmad, R.N. (240) 858-3153 iqra.ahmad@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Jaydira Del Rivero, M.D. National Cancer Institute (NCI)
Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04447014    
Other Study ID Numbers: 200110
20-C-0110
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 21, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Clinical Outcome
Advice in the Management of Cancer
Patterns of Disease Progression
Response or Lack of Response to Therapeutic Interventions
Additional relevant MeSH terms:
Layout table for MeSH terms
Adrenocortical Carcinoma
Adrenal Cortex Neoplasms
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