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Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Martin Fassnacht, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00457587
First received: April 4, 2007
Last updated: June 16, 2013
Last verified: June 2013
History of Changes
  Purpose

Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis. Surgical resection of the tumor is the treatment of choice. However, even after complete resection more than 80 % of patients will experience recurrence of disease. Therefore, new treatment options are urgently needed. This pre-clinical study try to lay the foundations for a successful immunotherapy in patients with ACC.


Condition Phase
Adrenocortical Carcinoma
Cushing's Syndrome
 Phase 0

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Präklinische Studie Zur Etablierung Einer Immuntherapie für Das Nebennierenrindenkarzinom - Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • To find reasonable antigens for a vaccination therapy in ACC
  • To investigate the role of tumor-induced suppression in ACC

Biospecimen Retention:   Samples With DNA

whole blood for monocytes isolation serum urine


Enrollment: 70
Study Start Date: September 2005
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adrenocortical carcinoma

Criteria

Inclusion Criteria:

  • patients with histological proven adrenocortical carcinoma
  • healthy persons as control group
  • Life expectancy > 6 months

Exclusion Criteria:

  • autoimmune diseases
  • severe clinical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457587

Locations
Germany
Dept. of Medicine I, University of Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Principal Investigator: Martin Fassnacht, MD University of Wuerzburg
  More Information

Additional Information:
Homepage Dept. of Endocrinology, U Wuerzburg  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Martin Fassnacht, Professor for Internal Medicine and Endocrinology, University of Wuerzburg
ClinicalTrials.gov Identifier: NCT00457587     History of Changes
Other Study ID Numbers: Wue-Immuno-ACC-83/05
Study First Received: April 4, 2007
Last Updated: June 16, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Carcinoma
Cushing Syndrome
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
 Endocrine System Diseases
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases

ClinicalTrials.gov processed this record on June 18, 2013