NCT Number: NCT05518851
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.
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Observational
Peking University Third Hospital, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy.
Time frame: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. Recorded as "month".
Time frame: At the each scheduled follow-up visit through study completion, an average of 3 months
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".
Time frame: Through study completion, an average of 1 year.
Proportion of patients with CR and PR.
Time frame: At the time of treatment change, through study completion, an average of 3 months.
Date of initiation of primary treatment to date of new significant treatment.
Time frame: At the time of response, through study completion, an average of 3 months.
Date of initiation of treatment to date when criteria for response (PR or CR) first met.
Time frame: At the time of treatment failure, through study completion, an average of 3 months.
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.
Time frame: Baseline and at time of occurrence of death, through study completion, an average of 1 year.
Date of diagnosis to death from any cause.
Time frame: Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year.
Date of diagnosis to first date meets criteria for PD or death as a result of any cause
Time frame: Baseline and the time of death due to disease, through study completion, an average of 1 year.
Date of diagnosis to death as a result of disease
Time frame: 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.
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
Contact information is provided by the study sponsor or research team.
Peking University First Hospital
Other
Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China
Acronym: TACTICAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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