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Clinical Trials in China / NCT05518851
Recruiting Observational

TreAtments and outComes in paTients With prImary CutAneous Lymphoma

NCT05518851 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Observational
Started
2022-08-01
Last updated
2023-11-18

Condition(s) studied

Primary Cutaneous Lymphoma

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Type of significant therapies — 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.
  • Duration of significant therapies — 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".
  • Clinical response to significant therapies — 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".
  • Objective response rate(ORR) — Through study completion, an average of 1 year.
    Proportion of patients with CR and PR.
  • Time-to-next treatment (TTNT) — 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 to response (TTR) — 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 to treatment failure (TTF) — 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.

Trial sites (5)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality Recruiting
SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University Guandong Guangdong Recruiting
Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College Nanjing Jiangsu Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Peking University First Hospital Beijing China Recruiting

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BBM-L101 Gene Therapy in Participants With LGMD2D/R3 Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05518851 on ClinicalTrials.gov ↗ ← All trials in China