Natural History and Tissue Acquisition Study of Adrenocortical Carcinoma

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Brief Title

Natural History and Tissue Acquisition Study of Adrenocortical Carcinoma

Official Title

Natural History and Tissue Acquisition Study of Adrenocortical Carcinoma

Brief Summary

      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.

        -  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 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. A bio-specimen repository will be a major step
           towards more comprehensive studies of this very rare and unusual tumor, and allow us to
           begin to characterize subgroups within the disease.

        -  Patients with rare tumors seek expert advice in the management of their care. Dr. Fojo
           has such expertise and is frequently asked to consult in the care of ACC patients
           throughout the world. A natural history study would establish a more formal mechanism
           for such referrals, while allowing the systematic collection of epidemiologic data as
           well as much needed tumor samples.

      Objective:

      -To characterize the natural history of adrenocortical cancer, and in the process, collect
      blood, and tissue samples to study genetic/biochemical pathways involved in the development
      and progression of adrenocortical cancer (ACC).

      Eligibility:

        -  Patients greater than or equal to 12 years of age with biopsy-proven ACC

        -  Patients greater than or equal to 12 years of age suspected of having ACC

      Design/Schema:

        -  Patients will be offered clinical consultation with treatment recommendations, including
           standard of care and clinical trial options. Computed tomography scans of the thorax,
           abdomen and pelvis will be performed for staging purposes as indicated; occasionally,
           magnetic resonance imaging will be performed for the visualization of lesions in the
           liver, spine, or other anatomic sites.

        -  Medical histories will be documented 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. Tumor growth rates
           will also be calculated throughout the course of the disease.

        -  Blood and tumor samples will be obtained at baseline and at follow-up intervals when
           surgery is indicated. Tumor samples may include samples harvested at other facilities
           during or prior to enrollment on this trial.

        -  Genetic and epigenetic analysis of tumors and in selected cases expression array
           analysis will be performed.
    

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.

        -  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 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. A bio-specimen repository will be a major step
           towards more comprehensive studies of this very rare and unusual tumor, and allow us to
           begin to characterize subgroups within the disease.

        -  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 data as well as much needed tumor samples.

      Objective:

      -To characterize the natural history of adrenocortical cancer, and in the process, collect
      blood, and tissue samples to study genetic/biochemical pathways involved in the development
      and progression of adrenocortical cancer (ACC).

      Eligibility:

        -  Patients greater than or equal to 12 years of age with biopsy-proven ACC

        -  Patients greater than or equal to 12 years of age suspected of having ACC

      Design/Schema:

        -  Patients will be offered clinical consultation with treatment recommendations, including
           standard of care and clinical trial options. Computed tomography scans of the thorax,
           abdomen and pelvis will be performed for staging purposes as indicated; occasionally,
           magnetic resonance imaging will be performed for the visualization of lesions in the
           liver, spine, or other anatomic sites.

        -  Medical histories will be documented 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. Tumor growth rates
           will also be calculated throughout the course of the disease.

        -  Blood and tumor samples will be obtained at baseline and at follow-up intervals when
           surgery is indicated. Tumor samples may include samples harvested at other facilities
           during or prior to enrollment on this trial.

        -  Genetic and epigenetic analysis of tumors and in selected cases expression array
           analysis will be performed.
    


Study Type

Observational


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.

Secondary Outcome

 Establish a bio-specimen repository for genetic and epigenetic analysis of tumors and in selected cases for expression array analysis by collecting blood, and tissue samples to study the biology of ACC development and progression.

Condition

Adrenocortical Carcinoma



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

67

Start Date

December 13, 2013

Completion Date

March 2, 2018

Primary Completion Date

October 16, 2015

Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Patients greater than or equal to 12 years of age with biopsy-proven ACC that has been
             confirmed by the Laboratory of Pathology, NCI.

          -  Patients greater than or equal to 12 years of age suspected of having ACC. Patients
             with suspected ACC will undergo baseline workup at the clinical center and be referred
             for definitive surgical diagnosis and treatment.

          -  Ability of subject or Legally Authorized Representative to understand and the
             willingness to sign a written informed consent document.
      

Gender

All

Ages

12 Years - 100 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jeremy L Davis, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02015026

Organization ID

140029

Secondary IDs

14-C-0029

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Jeremy L Davis, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

March 2, 2018