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

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Brief Title

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

Official Title

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

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....
    

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

Observational


Primary Outcome

response to treatment


Condition

Adrenocortical Carcinoma


Study Arms / Comparison Groups

 1
Description:  Medical records of subjects enrolled on various ACC studies conducted by CCR

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

250

Start Date

July 15, 2020

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        -  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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Jaydira Del Rivero, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04358107

Organization ID

999920095

Secondary IDs

20-C-N095

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

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


Verification Date

April 20, 2020