TreAtments and outComes in paTients With prImary CutAneous Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Primary Cutaneous Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients who fail to provide informed consent form. Patients who cannot complete the questionnaire independently or under the guidance of investigators.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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China, Primary Cutaneous Lymphoma, Treatment, Survival, Non-Hodgkin's Lymphoma