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Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457587
First Posted: April 6, 2007
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Martin Fassnacht, University of Wuerzburg
  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
Adrenocortical Carcinoma Cushing's Syndrome

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:


Further study details as provided by Martin Fassnacht, University of Wuerzburg:

Primary Outcome Measures:
  • To find reasonable antigens for a vaccination therapy in ACC [ Time Frame: day of blood sampling ]
  • To investigate the role of tumor-induced suppression in ACC [ Time Frame: NA, in vitro study ]

Biospecimen Retention:   Samples With DNA
whole blood for monocytes isolation serum urine

Enrollment: 70
Study Start Date: September 2005
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 4, 2007
First Posted: April 6, 2007
Last Update Posted: May 9, 2017
Last Verified: May 2017

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