Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC.
Elise A Olsen, Sean Whittaker, Rein Willemze...
https://pubmed.ncbi.nlm.nih.gov/34758074Actively Recruiting
Age: 18Years - 75Years
All Genders
ID06436677
A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
Led by Peking University First Hospital · Updated on 2024-05-31
100
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
P
Peking University Third Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how using molecular subtyping and immunohistochemistry to guide treatment choices can affect patients with cutaneous T-cell lymphoma (CTCL). This group of diseases involves abnormal growth of certain T cells in the skin and has challenges such as rising cases, high treatment costs, variable remission times, and recurrence. The study aims to improve treatment safety, extend clinical benefits, and reduce economic burdens by tailoring therapies based on molecular classification. Patients with confirmed CTCL will have their skin lesions analyzed using an immunohistochemistry algorithm to assign molecular subtypes. Treatment strategies will then be selected according to these subtypes, for example, interferon-based immunomodulatory therapy for TCyEM patients and retinoids for TCM-type patients. The study includes a prospective group receiving subtype-based treatments and a retrospective control group from a database of past cases with complete baseline information. Participants will be followed for up to two years, during which researchers will monitor time to next treatment, response rates, progression-free survival, and overall survival. Data will be collected on clinical benefits and long-term prognosis, as well as treatment safety. The study is observational and does not involve experimental drug administration, focusing instead on evaluating existing treatment strategies guided by molecular classification.
CONDITIONS
Brief Title
A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed with cutaneous T-cell lymphoma not responding well to topical corticosteroids, nitrogen mustard, or phototherapy in early or advanced stages
- Aged between 18 and 75 years
- Expected survival time longer than 3 months
- For historical controls, follow-up data available longer than 3 months
You will not qualify if you...
- Received anti-tumor therapy other than skin-targeted treatments within the last month
- Diagnosed with two or more types of primary cutaneous T-cell lymphoma simultaneously
- Have other malignant tumors and currently receiving anti-tumor therapy
- Have active diseases increasing treatment risk or impairing ability to follow protocol, such as epilepsy, autoimmune diseases, hepatic decompensation, or renal insufficiency (creatinine clearance < 50 ml/min)
- Have uncontrollable medical conditions including active infection, healing or non-healing wounds, symptomatic heart failure, unstable angina, significant arrhythmias, or significant lung disease
- Have conditions affecting study compliance like infectious diseases or psychiatric/social issues
- Pregnant, breastfeeding, or planning pregnancy within 2 years
- Participating in other interventional clinical trials except for questionnaires or observational studies
- Any situation not compliant with the study protocol
- Other conditions judged unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Monitoring
Duration - Up to 2 years
Participants are observed according to their molecular subtype classification and treatment strategy selection based on immunohistochemistry. The study evaluates clinical benefit time, safety, and long-term prognosis.
Visits as scheduled based on treatment and follow-up needs
Trial Site Locations
Total: 3 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
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Research Team
Y
Yang Wang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Prognostic Factors and Survival Outcomes Among Patients With Mycosis Fungoides in China: A 12-Year Review.
Zhuojing Chen, Yuwei Lin, Yao Qin...
https://pubmed.ncbi.nlm.nih.gov/37585188