Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:28 AM
Study NCT ID:
NCT01002560
Status:
UNKNOWN
Last Update Posted:
2009-10-27
First Post:
2009-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Identification of Novel Prognostic Markers in Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-26', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Given that the nature of the research is qualitative, there is no primary outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Novel Prognostic Markers'], 'conditions': ['Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to analyze tumour tissue from a group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital.', 'detailedDescription': 'Background - The Royal Marsden Hospital and the Institute of Cancer Research constitute the largest comprehensive cancer centre in Europe. In addition to an in-house drug development program, phase I - phase III clinical trials of novel anti-cancer agents are hosted. In order to investigate the optimal use of novel molecularly targeted agents, access to clinical tumour samples is needed in order to determine which particular cancer type expresses a molecular "signature" that may indicate potential therapeutic utility. Understanding such signatures should accelerate the registration of new drugs for routine cancer therapy; offering the potential of selecting those patients with tumour types most likely to benefit from therapy. Furthermore, new insights into disease biology may be gained.\n\nMain research question/ objective - Are there features of primary melanoma or lymph node metastases that predict subsequent clinical outcome better than existing markers?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of melanoma\n* Adequate paraffin-embedded material available for analysis.\n* Adequate clinical follow-up information\n* Written informed consent where applicable\n\nExclusion Criteria:\n\n* Inadequate paraffin-embedded material available\n* Inadequate clinical follow-up information.'}, 'identificationModule': {'nctId': 'NCT01002560', 'briefTitle': 'The Identification of Novel Prognostic Markers in Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Novel Prognostic Markers in Melanoma: a Protocol for the Analysis of Paraffin-embedded Tumour Samples', 'orgStudyIdInfo': {'id': 'CCR3078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malignant melanoma tumour tissue'}, {'label': 'Benign pigmented lesions & other skin cancers', 'description': 'Normal skin, benign melanocytic tumours, and skin cancers from lineages other than melanocytic, to be used as negative controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'centralContacts': [{'name': 'Professor Martin Gore', 'role': 'CONTACT', 'email': 'martin.gore@rmh.nhs.uk', 'phone': '02078082198'}], 'overallOfficials': [{'name': 'Professor Martin Gore', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Martin Gore', 'oldOrganization': 'Royal Marsden NHS Foundation Trust'}}}}