Adrenocortical CarcinomaNCT04447014
Natural History Study of Children and Adults With Adrenocortical Cancer (ACC)
An observational study of Adrenocortical Carcinoma and Adrenocortical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Adrenocortical Carcinoma, Adrenocortical Cancer
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 12 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Natural History Study of Children and Adults With Adrenocortical Cancer
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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Adrenocortical Carcinoma, Adrenal Cortex Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects with confirmed adrenocortical cancer (ACC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start25 Jun 2020
- Primary completion27 Jun 2022
- Study completion12 Jan 2023
Why it stopped: To avoid the duplication of resources and effort associated with the PI switching branches.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jaydira Del Rivero, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447014
- Sponsor's protocol ID
- 200110
- Other IDs
- 20-C-0110
- Status last verified
- Jan 2023
- First submitted
- 24 Jun 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study of Children and Adults With Adrenocortical Cancer
- ClinicalTrials.gov ID
- NCT04447014
- Acronym / sponsor ID
- 200110
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: To avoid the duplication of resources and effort associated with the PI switching branches.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Subjects with confirmed adrenocortical cancer (ACC) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: To avoid the duplication of resources and effort associated with the PI switching branches.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaydira Del Rivero, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenocortical Carcinoma and Adrenocortical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: To avoid the duplication of resources and effort associated with the PI switching branches.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.