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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Type of significant therapies | The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. | At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months |
| Duration of significant therapies | The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. Recorded as "month". | At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months |
| Clinical response to significant therapies | 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". | At the each scheduled follow-up visit through study completion, an average of 3 months |
| Objective response rate(ORR) | Proportion of patients with CR and PR. | Through study completion, an average of 1 year. |
| Time-to-next treatment (TTNT) | Date of initiation of primary treatment to date of new significant treatment. | At the time of treatment change, through study completion, an average of 3 months. |
| Time to response (TTR) | Date of initiation of treatment to date when criteria for response (PR or CR) first met. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Date of diagnosis to death from any cause. | Baseline and at time of occurrence of death, through study completion, an average of 1 year. |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wang, MD | Contact | (86)-10-83572350 | yangwang_dr@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yang Wang, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34758074 | Background | 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. | |
| 15692063 |
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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.
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| At the time of response, through study completion, an average of 3 months. |
| Time to treatment failure (TTF) | 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. | At the time of treatment failure, through study completion, an average of 3 months. |
Date of diagnosis to first date meets criteria for PD or death as a result of any cause
| Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year. |
| Disease Specific Survival (DSS) | Date of diagnosis to death as a result of disease | Baseline and the time of death due to disease, through study completion, an average of 1 year. |
| Disease Free Survival (DFS) | 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 | 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. |
| SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University | Recruiting | Guandong | Guangdong | 510235 | China |
|
| Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College | Recruiting | Nanjing | Jiangsu | 210042 | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
|
| Peking University First Hospital | Recruiting | Beijing | China |
|
| Background |
| 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. |
| 30635287 | Background | 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. |
| 17540844 | Background | 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. |
| 24438970 | Background | 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. |
| 24438969 | Background | 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. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |