Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 4:11 AM
Study NCT ID:
NCT00669266
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adrenal Tumors - Pathogenesis and Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D018268', 'term': 'Adrenocortical Carcinoma'}, {'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D006929', 'term': 'Hyperaldosteronism'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000306', 'term': 'Adrenal Cortex Neoplasms'}, {'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}, {'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Germline DNA Tumor samples Serum Plasma Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2008-04-28', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adrenal Tumors', 'Adrenocortical Carcinoma', 'Cushing Syndrome', 'Conn Syndrome', 'Pheochromocytoma']}, 'referencesModule': {'references': [{'pmid': '35583844', 'type': 'RESULT', 'citation': 'Tamburello M, Altieri B, Sbiera I, Sigala S, Berruti A, Fassnacht M, Sbiera S. FGF/FGFR signaling in adrenocortical development and tumorigenesis: novel potential therapeutic targets in adrenocortical carcinoma. Endocrine. 2022 Sep;77(3):411-418. doi: 10.1007/s12020-022-03074-z. Epub 2022 May 18.'}, {'pmid': '34956100', 'type': 'RESULT', 'citation': 'Sbiera I, Kircher S, Altieri B, Lenz K, Hantel C, Fassnacht M, Sbiera S, Kroiss M. Role of FGF Receptors and Their Pathways in Adrenocortical Tumors and Possible Therapeutic Implications. Front Endocrinol (Lausanne). 2021 Dec 9;12:795116. doi: 10.3389/fendo.2021.795116. eCollection 2021.'}, {'pmid': '33608270', 'type': 'RESULT', 'citation': 'Weigand I, Ronchi CL, Vanselow JT, Bathon K, Lenz K, Herterich S, Schlosser A, Kroiss M, Fassnacht M, Calebiro D, Sbiera S. PKA Calpha subunit mutation triggers caspase-dependent RIIbeta subunit degradation via Ser114 phosphorylation. Sci Adv. 2021 Feb 19;7(8):eabd4176. doi: 10.1126/sciadv.abd4176. Print 2021 Feb.'}, {'pmid': '32184394', 'type': 'RESULT', 'citation': 'Weigand I, Schreiner J, Rohrig F, Sun N, Landwehr LS, Urlaub H, Kendl S, Kiseljak-Vassiliades K, Wierman ME, Angeli JPF, Walch A, Sbiera S, Fassnacht M, Kroiss M. Active steroid hormone synthesis renders adrenocortical cells highly susceptible to type II ferroptosis induction. Cell Death Dis. 2020 Mar 17;11(3):192. doi: 10.1038/s41419-020-2385-4.'}, {'pmid': '27389594', 'type': 'RESULT', 'citation': 'Ronchi CL, Di Dalmazi G, Faillot S, Sbiera S, Assie G, Weigand I, Calebiro D, Schwarzmayr T, Appenzeller S, Rubin B, Waldmann J, Scaroni C, Bartsch DK, Mantero F, Mannelli M, Kastelan D, Chiodini I, Bertherat J, Reincke M, Strom TM, Fassnacht M, Beuschlein F; European Network for the Study of Adrenocortical Tumors (ENSAT). Genetic Landscape of Sporadic Unilateral Adrenocortical Adenomas Without PRKACA p.Leu206Arg Mutation. J Clin Endocrinol Metab. 2016 Sep;101(9):3526-38. doi: 10.1210/jc.2016-1586. Epub 2016 Jul 7.'}, {'pmid': '24571724', 'type': 'RESULT', 'citation': "Beuschlein F, Fassnacht M, Assie G, Calebiro D, Stratakis CA, Osswald A, Ronchi CL, Wieland T, Sbiera S, Faucz FR, Schaak K, Schmittfull A, Schwarzmayr T, Barreau O, Vezzosi D, Rizk-Rabin M, Zabel U, Szarek E, Salpea P, Forlino A, Vetro A, Zuffardi O, Kisker C, Diener S, Meitinger T, Lohse MJ, Reincke M, Bertherat J, Strom TM, Allolio B. Constitutive activation of PKA catalytic subunit in adrenal Cushing's syndrome. N Engl J Med. 2014 Mar 13;370(11):1019-28. doi: 10.1056/NEJMoa1310359. Epub 2014 Feb 26."}]}, 'descriptionModule': {'briefSummary': 'The pathogenesis of adrenal tumors is still not fully elucidated and the treatment options for malignant tumors are poor. The current study investigates different aspects of the pathogenesis of adrenal tumors and evaluates different therapeutic options in patients with adrenocortical carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with adrenal tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adrenal tumor detected by imaging\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00669266', 'briefTitle': 'Adrenal Tumors - Pathogenesis and Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Wuerzburg'}, 'officialTitle': 'Investigation of the Tumorigenesis of Adrenal Tumors and Evaluation of New Therapeutic Options - Untersuchungen Zur Tumorgenese Von Nebennierentumoren Und Evaluation Neuer Therapieoptionen', 'orgStudyIdInfo': {'id': 'Wue-Adrenal-Tumors-92/2002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tumor', 'description': 'Tumor material and corresponding biosamples from patients with adrenal tumors'}, {'label': 'control group', 'description': 'Biomaterial from patients without adrenal tumor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Fassnacht, MD', 'role': 'CONTACT', 'email': 'fassnacht_m@medizin.uni-wuerzburg.de'}, {'name': 'Stefanie Hahner, MD', 'role': 'CONTACT', 'email': 'hahner_s@medizin.uni-wuerzburg.de'}, {'name': 'Martin Fassnacht, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Martin Fassnacht, MD', 'role': 'CONTACT', 'email': 'fassnacht_m@medizin.uni-wuerzburg.de', 'phone': '49-931-201-36507'}], 'overallOfficials': [{'name': 'Martin Fassnacht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U of Wuerzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wuerzburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endocrinology', 'investigatorFullName': 'Martin Fassnacht', 'investigatorAffiliation': 'University of Wuerzburg'}}}}