Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-03-02 @ 6:09 PM
Study NCT ID:
NCT01398306
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '2 x 10mL whole blood, stored as platelet rich and platelet poor plasma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in concentrations DA and 5-HT in thrombocytes of patients with clear cell renal cell carcinoma and healthy controls, and patients with low grade neuroendocrine tumours and healthy controls.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Difference in concentrations DA and 5-HT in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours with and without medication.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Angiogenesis Inhibitors', 'Neoplasms, Glandular and Epithelial', 'Neoplasms by Histologic Type', 'Neoplasms', 'Adenocarcinoma', 'Kidney Neoplasms', 'Urologic Neoplasms', 'Urogenital Neoplasms', 'Neoplasms by Site', 'Kidney Diseases', 'Angiogenesis Inducing Agents', 'Biological Markers'], 'conditions': ['Carcinoma', 'Carcinoma, Renal Cell', 'Neuroendocrine Tumors', 'Carcinoid Tumor', 'Pancreatic Islet Cell Tumors']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to analyse the concentration dopamine and serotonin in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to the concentrations of these catecholamines in healthy volunteers. The concentration dopamine and serotonin in thrombocytes with and without medication will also be evaluated.', 'detailedDescription': '* To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours.\n* To compare these concentrations with the concentrations catecholamines in thrombocytes of healthy controls.\n* To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and patients with low grade neuroendocrine tumours with and without medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clear cell renal cell carcinoma with metastases and patients with low grade neuroendocrine tumours with metastases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years old or older.\n* Patients with clear cell renal cell carcinoma with metastases or patients with a low-grade neuro-endocrine tumor with metastases.\n* Written informed consent\n\nExclusion Criteria:\n\n* Use of L-dopa or SSRI.\n* Patients with a second primary malignancy.'}, 'identificationModule': {'nctId': 'NCT01398306', 'acronym': 'BANN', 'briefTitle': 'Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.', 'orgStudyIdInfo': {'id': '230520112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients with clear cell renal cell carcinoma with metastases.', 'interventionNames': ['Other: Blood sampling by vena punction.']}, {'label': 'Group B', 'description': 'Patients with low grade neuro-endocrine tumours with metastases.', 'interventionNames': ['Other: Blood sampling by vena punction.']}], 'interventions': [{'name': 'Blood sampling by vena punction.', 'type': 'OTHER', 'description': 'We obtain 10mL blood of the patients. The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Sjoukje F. Oosting, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Marloes A.M. Peters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}