- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358107
Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC)
Retrospective Study of Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC)
Background:
Adrenocortical carcinoma (ACC) is a rare cancer. It has a poor prognosis. Some people live with ACC for years; others live for just months. The average survival from the time of diagnosis is 14.5 months. Researchers do not know if local directed treatments may work better than systemic ones. They want to learn more about ACC by looking at data from previous studies.
Objective:
To characterize the overall prognosis and treatment responses in people with ACC with various systemic therapies and correlate them with age, sex, race, and disease burden.
Eligibility:
People with ACC enrolled on any of the following studies: 92-C-0268, 93-C-0200, 00-C-0044, 01-C-0129, 04-C-0011, 09-C-0242, 08-C-0176, 10-C-0203, 13-C-0114, and 14-C-0029
Design:
Study researchers will review participants medical records. They will collect the following data:
Medical record numbers
Demographics (such as age, sex, and race)
Treatments (such as surgeries, radiology procedures, and systemic treatments)
Time of disease progression between treatments and genetic/molecular data (if available)
Time of diagnosis/time of death.
All data will be kept in secure network drives or sites.
Participants who opted out of future use of data on their prior studies will be not be included in this study....
Study Overview
Status
Conditions
Detailed Description
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.
The natural history of ACC can vary greatly ranging from an aggressive course with patient survival measured in months to a more indolent course with patients living with the disease for years. The basis for these differing clinical presentations is not known. Therefore, accurate survival predictions in ACC are difficult and tumor classification methods with better clinical prognostic value are needed to help rationally guide the clinical management of patients with ACC. Over the last 20+ years in the CCR we have seen patients with ACC in different stages of their disease receiving various types of therapies from local directed therapies to systemic therapies, however, we have been unable to determine if local therapies may improve survival compared to the approved systemic therapies.
In this study, we plan to characterize the overall prognosis and treatment responses among patients with ACC with various systemic therapies and correlate with age, sex, race and disease burden. Identifiers will be recorded in order to correlate outcomes with therapy.
The study will involve review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled various ACC studies conducted by CCR. The Principal Investigators of each protocol have been contacted and have given permission to conduct this study and have verified that none of the original protocols or informed consent documents precludes such a review of clinical data. Participants who did not consent to future research will be excluded.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Patients enrolled on any of the studies listed below:
- 92-C-0268, 93-C-0200, 00-C-0044, 01-C-0129, 04-C-001, 09-C-0242, 08-C-0176, 10-C-0203, 13-C-0114, 14-C-0029
EXCLUSION CRITERIA:
-Patients who opted out of future use of data on their prior studies will be excluded from this study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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1
Medical records of subjects enrolled on various ACC studies conducted by CCR
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response to treatment
Time Frame: ongoing
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prognosis and treatment responses among patients with ACC correlated with age, sex, race and disease burden
|
ongoing
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jaydira Del Rivero, M.D., National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Disease Attributes
- Endocrine Gland Neoplasms
- Adrenal Gland Diseases
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Disease Progression
- Adrenocortical Carcinoma
- Adrenal Cortex Neoplasms
Other Study ID Numbers
- 999920095
- 20-C-N095
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adrenocortical Carcinoma
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National Cancer Institute (NCI)TerminatedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Adrenocortical Carcinoma | Stage III Adrenocortical Carcinoma | Stage IV Adrenocortical CarcinomaUnited States
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Dartmouth-Hitchcock Medical CenterM.D. Anderson Cancer Center; Dana-Farber Cancer Institute; AstraZeneca; Kentuckiana...CompletedNonresectable Adrenocortical CarcinomaUnited States
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Latin American Cooperative Oncology GroupNot yet recruitingCarcinoma Adrenal | Carcinoma, Adrenocortical RecurrentBrazil
-
Memorial Sloan Kettering Cancer CenterRecruitingAdrenocortical Carcinoma | ACC | Metastatic Adrenocortical CarcinomaUnited States
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Burzynski Research InstituteTerminatedStage IV Adrenocortical CarcinomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedAdrenocortical Carcinoma
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National Cancer Institute (NCI)CompletedAdrenal Cortex NeoplasmsUnited States
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National Cancer Institute (NCI)RecruitingNeuroendocrine Tumors | Carcinoma, Neuroendocrine | Neuroendocrine Carcinomas | Carcinoma, Adrenal Cortical | Carcinoma, AdrenocorticalUnited States
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University Medical Center GroningenRadboud University Medical Center; Maastricht University Medical Center; UMC... and other collaboratorsRecruitingAdrenocortical Carcinoma | Adrenal IncidentalomaNetherlands