TreAtments and outComes in paTients With prImary CutAneous Lymphoma

NCT ID: NCT05518851

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2032-08-31

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.

Conditions

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Primary Cutaneous Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang WANG

Department of Dermatology and Venereology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University

Guandong, Guangdong, China

Site Status RECRUITING

Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College

Nanjing, Jiangsu, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Peking University First Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Wang, MD

Role: CONTACT

(86)-10-83572350

Facility Contacts

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Chunlei Zhang, MD

Role: primary

Fengjie Liu, PhD

Role: primary

Hao Chen, MD

Role: primary

Xiangjun Liu, PhD

Role: primary

Yang Wang, MD

Role: primary

References

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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: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC. Blood. 2022 Aug 4;140(5):419-437. doi: 10.1182/blood.2021012057.

Reference Type BACKGROUND
PMID: 34758074 (View on PubMed)

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 3.

Reference Type BACKGROUND
PMID: 15692063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30635287 (View on PubMed)

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 the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31.

Reference Type BACKGROUND
PMID: 17540844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24438970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24438969 (View on PubMed)

Other Identifiers

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PKU2022265

Identifier Type: -

Identifier Source: org_study_id

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