<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233335</url>
  </required_header>
  <id_info>
    <org_study_id>201305026RINC</org_study_id>
    <nct_id>NCT02233335</nct_id>
  </id_info>
  <brief_title>The Factors Associated With the Recurrence in Patients With Cushing Disease</brief_title>
  <official_title>The Factors Associated With the Recurrence in Patients With Cushing Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cushing syndrome refers the manifestations induced by chronic glucocorticoid excess and may&#xD;
      arise from various causes. Iatrogenic Cushing syndrome accounts for most patients, when they&#xD;
      are given exogenous glucocorticoid treatment. In contrast, spontaneous Cushing syndrome&#xD;
      results from endogenous glucocorticoid over-secretion. Although Cushing disease is rare, it&#xD;
      is the most common cause of spontaneous Cushing syndrome. The patient with Cushing disease&#xD;
      has a pituitary corticotroph adenoma, which overproduces adrenocorticotropic hormone (ACTH).&#xD;
      ACTH then stimulates adrenal gland to over-secret glucocorticoid. Patients with untreated&#xD;
      Cushing disease were shown to have poor prognosis, estimated a 5-year survival rate of 50%.&#xD;
      The first line treatment is tumor resection. Other managements include radiotherapy,&#xD;
      medication and bilateral adrenalectomy. The initial remission rate is high (66-90%). However,&#xD;
      some patients encounter with disease recurrence during follow-up.&#xD;
&#xD;
      The aim of this study is to clarify the factors associated with the recurrence after&#xD;
      treatment. In this study, we will review the patients with Cushing disease thoroughly and&#xD;
      analyze associated predisposing factors. These risk factors can remind the clinical physician&#xD;
      to early detect the recurrent disease in these patients, and further prevent morbidity and&#xD;
      mortality in their later lives.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with disease persistence or recurrence after surgery, which was determined by clinical symptoms, biochemical lab, dynamic test and image study</measure>
    <time_frame>participants were followed at 3 months after treatment for short-term outcome measure and followed until the last hospital visit, an average of 4.7 years, for long-term outcome measure</time_frame>
  </primary_outcome>
  <enrollment type="Actual">42</enrollment>
  <condition>Cushing Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cushing's disease who presented to the National Taiwan University Hospital&#xD;
        between 1992 and 2011&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosed Cushing's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already received treatment in other hospital&#xD;
&#xD;
          -  Ectopic Cushing's syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tien-Chun Chang, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Internal Medicine, National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>PLOTZ CM, KNOWLTON AI, RAGAN C. The natural history of Cushing's syndrome. Am J Med. 1952 Nov;13(5):597-614. doi: 10.1016/0002-9343(52)90027-2. No abstract available.</citation>
    <PMID>12996538</PMID>
  </reference>
  <reference>
    <citation>Etxabe J, Vazquez JA. Morbidity and mortality in Cushing's disease: an epidemiological approach. Clin Endocrinol (Oxf). 1994 Apr;40(4):479-84. doi: 10.1111/j.1365-2265.1994.tb02486.x.</citation>
    <PMID>8187313</PMID>
  </reference>
  <reference>
    <citation>Swearingen B, Biller BM, Barker FG 2nd, Katznelson L, Grinspoon S, Klibanski A, Zervas NT. Long-term mortality after transsphenoidal surgery for Cushing disease. Ann Intern Med. 1999 May 18;130(10):821-4. doi: 10.7326/0003-4819-130-10-199905180-00015.</citation>
    <PMID>10366371</PMID>
  </reference>
  <reference>
    <citation>Lindholm J, Juul S, Jorgensen JO, Astrup J, Bjerre P, Feldt-Rasmussen U, Hagen C, Jorgensen J, Kosteljanetz M, Kristensen L, Laurberg P, Schmidt K, Weeke J. Incidence and late prognosis of cushing's syndrome: a population-based study. J Clin Endocrinol Metab. 2001 Jan;86(1):117-23. doi: 10.1210/jcem.86.1.7093.</citation>
    <PMID>11231987</PMID>
  </reference>
  <reference>
    <citation>Hammer GD, Tyrrell JB, Lamborn KR, Applebury CB, Hannegan ET, Bell S, Rahl R, Lu A, Wilson CB. Transsphenoidal microsurgery for Cushing's disease: initial outcome and long-term results. J Clin Endocrinol Metab. 2004 Dec;89(12):6348-57. doi: 10.1210/jc.2003-032180.</citation>
    <PMID>15579802</PMID>
  </reference>
  <reference>
    <citation>Dekkers OM, Biermasz NR, Pereira AM, Roelfsema F, van Aken MO, Voormolen JH, Romijn JA. Mortality in patients treated for Cushing's disease is increased, compared with patients treated for nonfunctioning pituitary macroadenoma. J Clin Endocrinol Metab. 2007 Mar;92(3):976-81. doi: 10.1210/jc.2006-2112. Epub 2007 Jan 2.</citation>
    <PMID>17200171</PMID>
  </reference>
  <reference>
    <citation>Clayton RN, Raskauskiene D, Reulen RC, Jones PW. Mortality and morbidity in Cushing's disease over 50 years in Stoke-on-Trent, UK: audit and meta-analysis of literature. J Clin Endocrinol Metab. 2011 Mar;96(3):632-42. doi: 10.1210/jc.2010-1942. Epub 2010 Dec 30.</citation>
    <PMID>21193542</PMID>
  </reference>
  <reference>
    <citation>Hassan-Smith ZK, Sherlock M, Reulen RC, Arlt W, Ayuk J, Toogood AA, Cooper MS, Johnson AP, Stewart PM. Outcome of Cushing's disease following transsphenoidal surgery in a single center over 20 years. J Clin Endocrinol Metab. 2012 Apr;97(4):1194-201. doi: 10.1210/jc.2011-2957. Epub 2012 Jan 25.</citation>
    <PMID>22278423</PMID>
  </reference>
  <reference>
    <citation>Atkinson AB, Kennedy A, Wiggam MI, McCance DR, Sheridan B. Long-term remission rates after pituitary surgery for Cushing's disease: the need for long-term surveillance. Clin Endocrinol (Oxf). 2005 Nov;63(5):549-59. doi: 10.1111/j.1365-2265.2005.02380.x.</citation>
    <PMID>16268808</PMID>
  </reference>
  <reference>
    <citation>Pikkarainen L, Sane T, Reunanen A. The survival and well-being of patients treated for Cushing's syndrome. J Intern Med. 1999 May;245(5):463-8. doi: 10.1046/j.1365-2796.1999.00483.x.</citation>
    <PMID>10363746</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ACTH-Secreting Pituitary Adenoma</mesh_term>
    <mesh_term>Pituitary ACTH Hypersecretion</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233335
org study id: 201305026RINC
nct id: NCT02233335
lead sponsor: 
has dmc: No
Cushing syndrome refers the manifestations induced by chronic glucocorticoid excess and may
      arise from various causes. Iatrogenic Cushing syndrome accounts for most patients, when they
      are given exogenous glucocorticoid treatment. In contrast, spontaneous Cushing syndrome
      results from endogenous glucocorticoid over-secretion. Although Cushing disease is rare, it
      is the most common cause of spontaneous Cushing syndrome. The patient with Cushing disease
      has a pituitary corticotroph adenoma, which overproduces adrenocorticotropic hormone (ACTH).
      ACTH then stimulates adrenal gland to over-secret glucocorticoid. Patients with untreated
      Cushing disease were shown to have poor prognosis, estimated a 5-year survival rate of 50%.
      The first line treatment is tumor resection. Other managements include radiotherapy,
      medication and bilateral adrenalectomy. The initial remission rate is high (66-90%). However,
      some patients encounter with disease recurrence during follow-up.

      The aim of this study is to clarify the factors associated with the recurrence after
      treatment. In this study, we will review the patients with Cushing disease thoroughly and
      analyze associated predisposing factors. These risk factors can remind the clinical physician
      to early detect the recurrent disease in these patients, and further prevent morbidity and
      mortality in their later lives.
observational model: Case-Control
time perspective: Retrospective
measure: Number of participants with disease persistence or recurrence after surgery, which was determined by clinical symptoms, biochemical lab, dynamic test and image study
time frame: participants were followed at 3 months after treatment for short-term outcome measure and followed until the last hospital visit, an average of 4.7 years, for long-term outcome measure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tien-Chun Chang, M.D., Ph.D.
role: Study Chair
affiliation: Department of Internal Medicine, National Taiwan University Hospital
facility: 
country: Taiwan
citation: PLOTZ CM, KNOWLTON AI, RAGAN C. The natural history of Cushing's syndrome. Am J Med. 1952 Nov;13(5):597-614. doi: 10.1016/0002-9343(52)90027-2. No abstract available.
PMID: 12996538
citation: Etxabe J, Vazquez JA. Morbidity and mortality in Cushing's disease: an epidemiological approach. Clin Endocrinol (Oxf). 1994 Apr;40(4):479-84. doi: 10.1111/j.1365-2265.1994.tb02486.x.
PMID: 8187313
citation: Swearingen B, Biller BM, Barker FG 2nd, Katznelson L, Grinspoon S, Klibanski A, Zervas NT. Long-term mortality after transsphenoidal surgery for Cushing disease. Ann Intern Med. 1999 May 18;130(10):821-4. doi: 10.7326/0003-4819-130-10-199905180-00015.
PMID: 10366371
citation: Lindholm J, Juul S, Jorgensen JO, Astrup J, Bjerre P, Feldt-Rasmussen U, Hagen C, Jorgensen J, Kosteljanetz M, Kristensen L, Laurberg P, Schmidt K, Weeke J. Incidence and late prognosis of cushing's syndrome: a population-based study. J Clin Endocrinol Metab. 2001 Jan;86(1):117-23. doi: 10.1210/jcem.86.1.7093.
PMID: 11231987
citation: Hammer GD, Tyrrell JB, Lamborn KR, Applebury CB, Hannegan ET, Bell S, Rahl R, Lu A, Wilson CB. Transsphenoidal microsurgery for Cushing's disease: initial outcome and long-term results. J Clin Endocrinol Metab. 2004 Dec;89(12):6348-57. doi: 10.1210/jc.2003-032180.
PMID: 15579802
citation: Dekkers OM, Biermasz NR, Pereira AM, Roelfsema F, van Aken MO, Voormolen JH, Romijn JA. Mortality in patients treated for Cushing's disease is increased, compared with patients treated for nonfunctioning pituitary macroadenoma. J Clin Endocrinol Metab. 2007 Mar;92(3):976-81. doi: 10.1210/jc.2006-2112. Epub 2007 Jan 2.
PMID: 17200171
citation: Clayton RN, Raskauskiene D, Reulen RC, Jones PW. Mortality and morbidity in Cushing's disease over 50 years in Stoke-on-Trent, UK: audit and meta-analysis of literature. J Clin Endocrinol Metab. 2011 Mar;96(3):632-42. doi: 10.1210/jc.2010-1942. Epub 2010 Dec 30.
PMID: 21193542
citation: Hassan-Smith ZK, Sherlock M, Reulen RC, Arlt W, Ayuk J, Toogood AA, Cooper MS, Johnson AP, Stewart PM. Outcome of Cushing's disease following transsphenoidal surgery in a single center over 20 years. J Clin Endocrinol Metab. 2012 Apr;97(4):1194-201. doi: 10.1210/jc.2011-2957. Epub 2012 Jan 25.
PMID: 22278423
citation: Atkinson AB, Kennedy A, Wiggam MI, McCance DR, Sheridan B. Long-term remission rates after pituitary surgery for Cushing's disease: the need for long-term surveillance. Clin Endocrinol (Oxf). 2005 Nov;63(5):549-59. doi: 10.1111/j.1365-2265.2005.02380.x.
PMID: 16268808
citation: Pikkarainen L, Sane T, Reunanen A. The survival and well-being of patients treated for Cushing's syndrome. J Intern Med. 1999 May;245(5):463-8. doi: 10.1046/j.1365-2796.1999.00483.x.
PMID: 10363746
responsible party type: Sponsor
mesh term: ACTH-Secreting Pituitary Adenoma
mesh term: Pituitary ACTH Hypersecretion
mesh term: Recurrence