Preclinical Study Towards an Immunotherapy in Adrenocorti... | NCT00457587

Studies
Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

NCT00457587

Sponsor

University of Wuerzburg

Status

Active, not recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Adrenocortical Carcinoma
Cushing's Syndrome

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2026

Last Update Posted Date

May 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Fassnacht, Professor for Internal Medicine and Endocrinology, University of WuerzburgPrincipal Investigator

Lead Sponsor

University of WuerzburgOTHER

Collaborators

Name	Class
Deutsche Krebshilfe e.V., Bonn (Germany)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To find reasonable antigens for a vaccination therapy in ACC		day of blood sampling
To investigate the role of tumor-induced suppression in ACC		NA, in vitro study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adrenocortical carcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Fassnacht, MD	University of Wuerzburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Medicine I, University of Wuerzburg		Würzburg		97080	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32474412	Result	Landwehr LS, Altieri B, Schreiner J, Sbiera I, Weigand I, Kroiss M, Fassnacht M, Sbiera S. Interplay between glucocorticoids and tumor-infiltrating lymphocytes on the prognosis of adrenocortical carcinoma. J Immunother Cancer. 2020 May;8(1):e000469. doi: 10.1136/jitc-2019-000469.

ID	Term
D018268	Adrenocortical Carcinoma
D003480	Cushing Syndrome

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type