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Trial Title:
TreAtments and outComes in paTients With prImary CutAneous Lymphoma
NCT ID:
NCT05518851
Condition:
Primary Cutaneous Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell, Cutaneous
Conditions: Keywords:
Primary Cutaneous Lymphoma
Treatment
Survival
China
Non-Hodgkin's Lymphoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunlei Zhang, MD
Email:
zhangchunleius@163.com
Facility:
Name:
SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University
Address:
City:
Guandong
Zip:
510235
Country:
China
Status:
Recruiting
Contact:
Last name:
Fengjie Liu, PhD
Email:
liufengjie119@163.com
Facility:
Name:
Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Address:
City:
Nanjing
Zip:
210042
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Chen, MD
Email:
ch76ch@163.com
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangjun Liu, PhD
Email:
ql09738@163.com
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Wang, MD
Email:
yangwang_dr@bjmu.edu.cn
Start date:
August 1, 2022
Completion date:
August 2032
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518851
