Natural History Study of Children and Adults With Adrenocortical Cancer (ACC)
-
- STATUS
- Recruiting
-
- End date
- Dec 31, 2028
-
- participants needed
- 300
-
- sponsor
- National Cancer Institute (NCI)
Summary
- Background
- Objective
To gain a better understanding of
- 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,
Participants may have
Participants will complete paper or electronic surveys. The surveys will ask about the
effects of
Participants will receive recommendations about how to manage their issues and potential
treatment options for their
Participants home physician will be contacted every 6 to 12 months to collect medical
information such as
Participants may be asked to return to the NIH every 6 to 12 months for follow-up
Participants will contact study staff if there are any changes in their
Participants will be followed on this study for life.
Description
- Background
-
Adrenocortical carcinoma (ACC) is a raretumor 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 ahereditary cancer predisposition syndrome.- The treatment of choice for a localized primary or recurrent
tumor is surgicalresection . Patients with recurrent ormetastatic disease are infrequently curable bysurgery alone. - As with most
solid tumors ,chemotherapy options have limited benefit, although platinumbasedtherapies have response rates of 25 to 30%. To dateno targeted therapy has been shown to be of any value in this disease. The role of neoadjuvant andadjuvant therapies , including systemicchemotherapy andradiotherapy , remains poorly defined and has been reported to have only a modest orno 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
- 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 andprogression , response totherapies , 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.
- This protocol is a subprotocol to protocol 19C0016 Natural History and Biospecimen
Accrual Study for Children and Adults with Rare
Details
| Condition |
Malignant neoplasm of |
|---|---|
| Age | 2years - 100years |
| Clinical Study Identifier | NCT04447014 |
| Sponsor | National |
| Last Modified on | 19 February 2024 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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