Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC)

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT04358107
Collaborator
(none)
1,000
1
44.4
22.5

Study Details

Study Description

Brief Summary

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....

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study of Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC)
    Actual Study Start Date :
    Apr 20, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Medical records of subjects enrolled on various ACC studies conducted by CCR

    Outcome Measures

    Primary Outcome Measures

    1. response to treatment [ongoing]

      prognosis and treatment responses among patients with ACC correlated with age, sex, race and disease burden

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute (NCI) Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jaydira Del Rivero, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04358107
    Other Study ID Numbers:
    • 999920095
    • 20-C-N095
    First Posted:
    Apr 22, 2020
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 12, 2022
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2022