- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538960
Epidemiology and Management of Cutaneous T-Cell Lymphoma at Hospital México, Costa Rica.
Epidemiological Profile and Therapeutic Management of Patients Diagnosed With Cutaneous T-cell Lymphoma Evaluated in the Dermatology Department of Hospital México During the Period From 2019 to 2025.
Study Overview
Status
Conditions
Detailed Description
This retrospective observational study will analyze adult patients (≥18 years) with a confirmed diagnosis of cutaneous T-cell lymphoma evaluated in the Dermatology Service of Hospital México between January 2019 and December 2025. Data will be obtained from electronic medical records (EDUS), including sociodemographic characteristics, clinical presentation, histopathological and immunohistochemical findings, disease staging, treatment modalities, and clinical outcomes.
Patients must have at least one documented dermatological evaluation and have received treatment, including skin-directed therapies and/or systemic therapies. Records that are incomplete, inconsistent, or lack histopathological confirmation will be excluded.
The study aims to characterize local epidemiological and therapeutic patterns and describe clinical outcomes using descriptive statistical analysis, providing updated real-world evidence to support clinical decision-making and optimize management strategies for cutaneous T-cell lymphoma in a national referral center.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Daniel Barquero-Orias, Dermatologist
- Phone Number: +506 83411026
- Email: debarque@ccss.sa.cr
Study Locations
-
-
Uruca
-
San José, Uruca, Costa Rica, 10107
- Hospital México
-
Contact:
- Daniel Barquero-Orias, Dermatologist
- Phone Number: +506 83411026
- Email: debarque@ccss.sa.cr
-
Principal Investigator:
- Raquel Ramirez-Fallas, Dermatology Resident
-
Sub-Investigator:
- Said Fallas-Moya, Dermatologist
-
Sub-Investigator:
- Daniel Barquero-Orias, Dermatologist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
he study population will consist of adult patients (≥18 years) of both sexes with a confirmed diagnosis of cutaneous T-cell lymphoma, established through clinical, histopathological, and immunohistochemical criteria, and documented in EDUS at the Dermatology Service of Hospital México between January 2019 and December 2025. Patients must have at least one recorded dermatological evaluation during the study period and must have received some form of treatment, including skin-directed therapies (phototherapy, topical treatments, localized radiotherapy) and/or systemic therapies.
Patients with insufficient or incomplete clinical records that prevent adequate diagnostic classification, staging, therapeutic characterization, or evaluation of clinical evolution will be excluded, as well as those with a presumptive diagnosis without histopathological confirmation, duplicate or inconsistent records, patients attended outside the study period, those outside the defined age range, and patients.
Description
Inclusion Criteria:
- Patients with a confirmed diagnosis of cutaneous T-cell lymphoma, established through clinical, histopathological, and immunohistochemical criteria, documented in EDUS of Hospital México in the Dermatology Service of Hospital México during the period between January 2019 and December 2025.
- Patients aged 18 years or older, of both sexes.
- Patients with at least one dermatological evaluation recorded during the study period.
- Patients who, having a confirmed diagnosis, have received some modality of treatment, including skin-directed therapies (phototherapy, topical treatments, localized radiotherapy) and/or systemic treatments.
Exclusion Criteria:
- Clinical records that are insufficient or incomplete, preventing adequate diagnostic classification, staging, therapeutic characterization, or evaluation of clinical evolution.
- Patients with a presumptive diagnosis of cutaneous T-cell lymphoma without histopathological confirmation.
- Duplicate or inconsistent records that hinder the correct identification and classification of the patient.
- Patients attended outside the established study period.
- Patients outside the age range.
- Patients who do not belong to the Dermatology Service of Hospital México.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterize the epidemiology
Time Frame: 2019-2025
|
Characterize the epidemiology of patients diagnosed with cutaneous T-cell lymphoma evaluated in the Dermatology Service of Hospital México.
|
2019-2025
|
|
Characterize the therapeutic management
Time Frame: 2019-2025.
|
Characterize the therapeutic management of patients diagnosed with cutaneous T-cell lymphoma evaluated in the Dermatology Service of Hospital México
|
2019-2025.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe the sociodemographic/epidemiological characteristics
Time Frame: 2019-2025
|
To describe the sociodemographic and epidemiological characteristics of patients diagnosed with cutaneous T-cell lymphoma evaluated in the Dermatology Service of Hospital México during the period from 2019 to 2025.
|
2019-2025
|
|
Classify the clinical manifestations/clinical subtypes
Time Frame: 2019-2025
|
Classify the clinical manifestations and clinical subtypes of cutaneous T-cell lymphoma present in the studied population.
|
2019-2025
|
|
Identify the histopathological/ immunohistochemical findings
Time Frame: 2019-2025
|
To identify the histopathological and immunohistochemical findings associated with cutaneous T-cell lymphoma in the included patients.
|
2019-2025
|
|
Analyze the therapeutic management modalities.
Time Frame: 2019-2025
|
Analyze the therapeutic management modalities used, including skin-directed therapies and their outcomes.
|
2019-2025
|
|
identify the clinical stage at the time of diagnosis
Time Frame: 2019-2025
|
identify the clinical stage of the disease at the time of diagnosis according to the TNMB staging system.
|
2019-2025
|
|
Evaluation of imaging studies and laboratory.
Time Frame: 2019-2025
|
Evaluate imaging studies and laboratory findings of patients with cutaneous T-cell lymphoma during the follow-up period.
|
2019-2025
|
|
Evaluation of clinical course and outcomes.
Time Frame: 2019-2025
|
Evaluation of clinical course and outcomes of patients with cutaneous T-cell lymphoma during the follow-up period.
|
2019-2025
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEC HM 002-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on T-cell Lymphoma
-
University of Alabama at BirminghamTerminatedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T-cell Lymphomas | Adult T-cell Leukemia | Adult T-cell Lymphoma | Peripheral T-cell Lymphoma Unspecified | T/Null Cell Systemic Type | Cutaneous t-Cell Lymphoma With Nodal/Visceral DiseaseUnited States
-
National Cancer Institute (NCI)WithdrawnHepatosplenic T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Adult T-cell Leukemia/Lymphoma | Extranodal NK-/T-cell Lymphoma, Nasal Type | Monomorphic Epiteliotrophic Intestinal T-cell LymphomaUnited States
-
BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Italy, Taiwan, France, Canada
-
National Cancer Institute (NCI)CompletedPeripheral T-Cell Lymphoma (PTCL) | T-Cell Prolymphocytic Leukemia | Cutaneous T Cell Lymphoma (CTCL) | T-Cell Lymphoma Relapsed | Adult T-Cell Leukemia (ATL)United States
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Yonsei University; Korea Cancer...CompletedCutaneous T Cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-negative | Angioimmunoblastic T Cell Lymphoma | Peripheral T Cell Lymphoma UnspecifiedKorea, Republic of
-
SciTech Development, Inc.Rush University Medical CenterRecruitingMycosis Fungoides | Cutaneous T-cell Lymphoma | Peripheral T-cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Cutaneous/Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Classified | Primary Cutaneous T-cell Lymphoma | Cutaneous T-Cell Lymphoma, Unspecified | Follicular... and other conditionsUnited States
-
Shanghai General Hospital, Shanghai Jiao Tong University...SuspendedAngioimmunoblastic T-cell Lymphoma | Peripheral T Cell Lymphoma | Anaplastic Lymphoma | Acute T Cell Leukemia | T-lymphoblastic LymphomaChina
-
Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States
-
Wuhan Union Hospital, ChinaWuhan Bio-Raid Biotechnology Co, Ltd. ChinaUnknownHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T Cell Lymphoma | NK/T-cell Lymphoma | Adult T-Cell Lymphoma/LeukaemiaChina
-
Karyopharm Therapeutics IncTerminatedCutaneous T-cell Lymphoma (CTCL) | Peripheral T-cell Lymphoma (PTCL)Australia, Singapore