UPCC 61424 Integration of Machine Learning and Genomics to Predict Outcomes for Newly Diagnosed, Relapsed and Refractory Mature T-cell and NK-cell Neoplasms: A Global Study of the PETAL Consortium (PETAL)
Investigating Genetic Factors in Certain Blood Cancers
Brief description of study
The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS), response rates for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning can be leveraged to uncover distinct genetic vulnerabilities that underlie treatment response and resistance for patients with TNKL, thus moving towards personalized treatment solutions.
Detailed description of study
This study is a prospective, longitudinal observational study of patients with newly diagnosed or relapsed/refractory T-cell and NK-cell neoplasms, conducted across multiple participating institutions globally. Patients will be enrolled during their initial visit as new patients and will be followed for up to four years through the course of their clinical management. Data for routine demographics, baseline clinical features, including pathology, molecular information related to the tumor, radiology, treatment characteristics and quality of life (QoL) associated with their lymphoma care will be collected over the course of 4 years by clinical research teams at every participating institution. The de-identified data will be securely shared through a password protected REDCap with other participating institutions under data usage agreements of the consortium. Next generation sequencing (NGS) including but not limited to whole exome sequencing and bulk RNA-sequencing will be performed on archived lymphoma specimens, mononuclear cells, cfDNA and saliva (when feasible) for a comprehensive molecular characterization of the tumor. Molecular data will be analyzed in correlation with patient outcomes. Advanced deep learning algorithms will be applied to predict responses and survival across lymphoma subtypes, heterogeneous clinical scenarios and various potential therapeutic approaches that the patient has not been exposed to.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: T-Cell and NK-Cell Neoplasm
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Untreated, relapsed, or refractory histologically confirmed mature T-cell or NK-cell neoplasm.
- All subtypes of PTCL are eligible except for T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders.
Exclusion Criteria:
- Precursor T/NK neoplasms, T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders.
- Adults who are unable to consent, individuals who are not yet adults such as infants, children and teenagers, pregnant women, and prisoners.
The purpose of this study is to investigate how molecular changes in mature T-cell and NK-cell neoplasms affect patient outcomes like survival and treatment response. This study involves patients who are newly diagnosed or have relapsed/refractory forms of these cancers. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
Participants will have their medical data collected over four years, including tumor characteristics and quality of life information. Advanced techniques like next-generation sequencing will be used to analyze genetic material from tumor samples. This data will be used to apply machine learning algorithms to predict patient outcomes and responses to different treatments.
- Who can participate: Adults with untreated, relapsed, or refractory mature T-cell or NK-cell neoplasms can participate, except those with certain subtypes like T-cell large granular lymphocytic leukemia or cutaneous T-cell lymphoma. Minors, pregnant women, prisoners, and those unable to consent are excluded.
- Study details: Participants will have their medical and genetic data collected over four years to understand the tumor's molecular makeup without altering their treatment.
- Study timelines: The study will last four years.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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