Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC)
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|ClinicalTrials.gov Identifier: NCT04358107|
Recruitment Status : Enrolling by invitation
First Posted : April 22, 2020
Last Update Posted : October 20, 2020
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.
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.
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
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....
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Retrospective Study of Optimal Methods of Disease Progression and Survival Analysis in Children and Adults With Adrenocortical Cancer (ACC)|
|Estimated Study Start Date :||October 23, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Medical records of subjects enrolled on various ACC studies conducted by CCR
- response to treatment [ Time Frame: ongoing ]prognosis and treatment responses among patients with ACC correlated with age, sex, race and disease burden
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): NCT04358107
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jaydira Del Rivero, M.D.||National Cancer Institute (NCI)|