A Global Study of the PETAL Consortium

Официальное название

Integration of Machine Learning and Genomics to Predict Outcomes for Newly Diagnosed, Relapsed and Refractory Mature T-cell and NK/T-cell Lymphomas: a Global Study of the PETAL Consortium

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Overall Survival [Срок оценки: Up to 4 Years]
• Progression-free Survival [Срок оценки: Up to 4 Years]
• Duration of Response [Срок оценки: Up to 4 Years]
• Time to progression [Срок оценки: Up to 4 Years]
• Number of subjects proceeding to stem cell transplantation [Срок оценки: Up to 4 Years]
• Association of tumor specific somatic variants with treatment response [Срок оценки: Up to 4 Years]

Вторичные конечные точки (3)

• Complete Response Rate [Срок оценки: Up to 4 Years]
• Overall Response Rate [Срок оценки: Up to 4 Years]
• Rate of Adverse Events [Срок оценки: Up to 4 Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 10 центров

• City of Hope — Duarte
• University of Colorado — Denver
• Moffitt Cancer Center — Tampa
• Massachusetts General Hospital — Boston
• Dana-Farber Cancer Institute — Boston
• Mayo Clinic — Rochester
• Hackensack University Medical Center — Hackensack
• OhioHealth — Columbus
• … и ещё 2 центра

Австралия · 2 центра

• Royal Adelaide Hospital — Adelaide
• Peter MacCallum Cancer Centre — Melbourne

Япония · 1 центр

• Kyoto University — Kyoto

ЮАР · 1 центр

• University of Cape Town — Cape Town

Идентификаторы

NCT: NCT06067347 · 23-212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗