TreAtments and outComes in paTients With prImary CutAneous Lymphoma

Официальное название

Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Type of significant therapies [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At the each scheduled follow-up visit through study completion, an average of 3 months]
• Objective response rate(ORR) [Срок оценки: Through study completion, an average of 1 year.]
• Time-to-next treatment (TTNT) [Срок оценки: At the time of treatment change, through study completion, an average of 3 months.]
• Time to response (TTR) [Срок оценки: At the time of response, through study completion, an average of 3 months.]
• Time to treatment failure (TTF) [Срок оценки: At the time of treatment failure, through study completion, an average of 3 months.]

Вторичные конечные точки (4)

• Overall survival (OS) [Срок оценки: Baseline and at time of occurrence of death, through study completion, an average of 1 year.]
• Progression Free Survival (PFS) [Срок оценки: 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) [Срок оценки: Baseline and the time of death due to disease, through study completion, an average of 1 year.]
• Disease Free Survival (DFS) [Срок оценки: 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.]

Критерии участия

Критерии включения

• Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.
• Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.

Критерии исключения

• Patients who fail to provide informed consent form.
• Patients who cannot complete the questionnaire independently or under the guidance of investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 5 центров

• Peking University Third Hospital — Пекин
• SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University — Guandong
• Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, — Нанкин
• Qilu Hospital of Shandong University — Цзинань
• Peking University First Hospital — Пекин

Публикации

• 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: r PMID 34758074
• 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 PMID 15692063
• 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 30635287
• 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 PMID 17540844
• 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 24438970
• 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. PMID 24438969

Идентификаторы

NCT: NCT05518851 · PKU2022265

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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