Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05518851
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TreAtments and outComes in paTients With prImary CutAneous Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2032-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of significant therapies', 'timeFrame': 'At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months', 'description': 'The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy.'}, {'measure': 'Duration of significant therapies', 'timeFrame': 'At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months', 'description': 'The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. Recorded as "month".'}, {'measure': 'Clinical response to significant therapies', 'timeFrame': 'At the each scheduled follow-up visit through study completion, an average of 3 months', 'description': 'Clinical response are assessed by consensus response criteria in PCLs (Olsen, Elise A et al. "Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC." Blood vol. 140,5 (2022): 419-437. ), recorded as "CR", "PR", "SD" or "PD".'}, {'measure': 'Objective response rate(ORR)', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Proportion of patients with CR and PR.'}, {'measure': 'Time-to-next treatment (TTNT)', 'timeFrame': 'At the time of treatment change, through study completion, an average of 3 months.', 'description': 'Date of initiation of primary treatment to date of new significant treatment.'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'At the time of response, through study completion, an average of 3 months.', 'description': 'Date of initiation of treatment to date when criteria for response (PR or CR) first met.'}, {'measure': 'Time to treatment failure (TTF)', 'timeFrame': 'At the time of treatment failure, through study completion, an average of 3 months.', 'description': 'Date of initiation of treatment until abandonment of therapy, causes of abandonment of therapy may include inadequate response to therapy, intolerable side effects or toxicity, disease progression, and patient withdrawal for whatever reason.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Baseline and at time of occurrence of death, through study completion, an average of 1 year.', 'description': 'Date of diagnosis to death from any cause.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year.', 'description': 'Date of diagnosis to first date meets criteria for PD or death as a result of any cause'}, {'measure': 'Disease Specific Survival (DSS)', 'timeFrame': 'Baseline and the time of death due to disease, through study completion, an average of 1 year.', 'description': 'Date of diagnosis to death as a result of disease'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'Date when criteria for CR first met and date when criteria for relapse/recurrence or or death from any cause, through study completion, an average of 1 year.', 'description': 'Date when criteria for CR first met until time of relapse/recurrence (if global CR, recurrence of disease in any one category) or death from any cause'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Cutaneous Lymphoma', 'Treatment', 'Survival', 'China', "Non-Hodgkin's Lymphoma"], 'conditions': ['Primary Cutaneous Lymphoma']}, 'referencesModule': {'references': [{'pmid': '34758074', 'type': 'BACKGROUND', 'citation': 'Olsen EA, Whittaker S, Willemze R, Pinter-Brown L, Foss F, Geskin L, Schwartz L, Horwitz S, Guitart J, Zic J, Kim YH, Wood GS, Duvic M, Ai W, Girardi M, Gru A, Guenova E, Hodak E, Hoppe R, Kempf W, Kim E, Lechowicz MJ, Ortiz-Romero P, Papadavid E, Quaglino P, Pittelkow M, Prince HM, Sanches JA, Sugaya M, Vermeer M, Zain J, Knobler R, Stadler R, Bagot M, Scarisbrick J. Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC. Blood. 2022 Aug 4;140(5):419-437. doi: 10.1182/blood.2021012057.'}, {'pmid': '15692063', 'type': 'BACKGROUND', 'citation': 'Willemze R, Jaffe ES, Burg G, Cerroni L, Berti E, Swerdlow SH, Ralfkiaer E, Chimenti S, Diaz-Perez JL, Duncan LM, Grange F, Harris NL, Kempf W, Kerl H, Kurrer M, Knobler R, Pimpinelli N, Sander C, Santucci M, Sterry W, Vermeer MH, Wechsler J, Whittaker S, Meijer CJ. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005 May 15;105(10):3768-85. doi: 10.1182/blood-2004-09-3502. Epub 2005 Feb 3.'}, {'pmid': '30635287', 'type': 'BACKGROUND', 'citation': 'Willemze R, Cerroni L, Kempf W, Berti E, Facchetti F, Swerdlow SH, Jaffe ES. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019 Apr 18;133(16):1703-1714. doi: 10.1182/blood-2018-11-881268. Epub 2019 Jan 11.'}, {'pmid': '17540844', 'type': 'BACKGROUND', 'citation': 'Olsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31.'}, {'pmid': '24438970', 'type': 'BACKGROUND', 'citation': 'Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome): part II. Prognosis, management, and future directions. J Am Acad Dermatol. 2014 Feb;70(2):223.e1-17; quiz 240-2. doi: 10.1016/j.jaad.2013.08.033.'}, {'pmid': '24438969', 'type': 'BACKGROUND', 'citation': 'Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome): part I. Diagnosis: clinical and histopathologic features and new molecular and biologic markers. J Am Acad Dermatol. 2014 Feb;70(2):205.e1-16; quiz 221-2. doi: 10.1016/j.jaad.2013.07.049.'}]}, 'descriptionModule': {'briefSummary': 'In order to further improve the diagnosis and treatment level of primary cutaneous lymphoma in China, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for primary cutaneous lymphoma to systematically and effectively understand the current treatment status of patients with primary cutaneous lymphoma, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of primary cutaneous lymphoma and help patients with primary cutaneous lymphoma.', 'detailedDescription': 'Primary cutaneous lymphomas (PCLs) are defined as non-Hodgkin lymphomas presenting in the skin with no evidence of extracutaneous disease at the time of diagnosis. Primary cutaneous lymphomas include a heterogeneous group of cutaneous T-cell lymphomas (CTCLs) and cutaneous B-cell lymphomas (CBCLs). The different types of PCLs have highly characteristic clinical and histologic features, often a completely different clinical behavior and prognosis, and require a different type of treatment. Various studied in terms of the treatment and outcome of patients with different types of PCLs has been conducted in recent years. While the data of Chinese patients with PCLs are limited. Considering the different proportion of PCLs and limited treatment modalities in China, a nationwide multi-center prospective study is designed to summarize the current treatment status and outcome of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will span over 10 years from enrollment to follow-up data collection. Recruitment for this study will occur in the medical clinic at each participating site. Patients with primary cutaneous lymphoma will be identified at participating medical units and these patients will be invited to participate in this study. The skin biopsy will be reviewed by at least two pathologists to confirm the diagnosis. After signing the institutional review board (IRB) approved informed consent, patients will be enrolled in the study and all intend data will be collected at baseline and each scheduled follow-up time.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.\n* Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.\n\nExclusion Criteria:\n\n* Patients who fail to provide informed consent form.\n* Patients who cannot complete the questionnaire independently or under the guidance of investigators.'}, 'identificationModule': {'nctId': 'NCT05518851', 'acronym': 'TACTICAL', 'briefTitle': 'TreAtments and outComes in paTients With prImary CutAneous Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China', 'orgStudyIdInfo': {'id': 'PKU2022265'}}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunlei Zhang, MD', 'role': 'CONTACT', 'email': 'zhangchunleius@163.com'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510235', 'city': 'Guandong', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fengjie Liu, PhD', 'role': 'CONTACT', 'email': 'liufengjie119@163.com'}], 'facility': 'SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University'}, {'zip': '210042', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Chen, MD', 'role': 'CONTACT', 'email': 'ch76ch@163.com'}], 'facility': 'Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangjun Liu, PhD', 'role': 'CONTACT', 'email': 'ql09738@163.com'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Wang, MD', 'role': 'CONTACT', 'email': 'yangwang_dr@bjmu.edu.cn'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Wang, MD', 'role': 'CONTACT', 'email': 'yangwang_dr@bjmu.edu.cn', 'phone': '(86)-10-83572350'}], 'overallOfficials': [{'name': 'Yang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will only be shared within the participating medical units in the study, including study protocol, informed consent form, clinical study report and statistical analysis plan. Any other institutes requesting for IPD needs to be reviewed by the National Clinical Center for Skin and Immune Diseases in China.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Dermatology and Venereology', 'investigatorFullName': 'Yang WANG', 'investigatorAffiliation': 'Peking University First Hospital'}}}}