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Идёт набор NCT05621837

Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

— Наблюдательное Melanoma Breast Cancer Renal Cell Carcinoma Urinary Bladder Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MDSC quantification.
Кому может быть актуально
Состояния в реестре: Melanoma, Breast Cancer, Renal Cell Carcinoma, Urinary Bladder Cancer. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.

Подробное описание

The study will demonstrate that this assay helps personalizing cancer therapies by tailoring them to immune patient features. The project will also take advantage of innovative and high-throughput techniques to define additional MDSC related biomarkers and, most importantly, to identify novel drugs for Myeloid-derived Suppressor Cells (MDSC) blocking in predisposed patients. Finally,it will perform the first survey assessing the link between MDSC and "perceived social isolation", an emerging western social problem recently shown to cause myeloid cell dysfunction and immunosuppression though neuroendocrine circuits. Globally, the Serpentine proposal has the ambitious goal to translate into the clinical oncological practise the use of MDSC quantification as a tool for the systematic assessment of systemic immunosuppression, providing at the same time operational insights into the strategies to overcome this pillar mechanism of cancer progression.

Вмешательства

  • Другое MDSC quantification
    Blood sample will be collected at baseline and during therapy, and, optionally, in case of disease progression (PD).

Первичные конечные точки

  • Immunological endpoint [Срок оценки: baseline, that is prior to start the therapy (Visit_1)]
  • Immunological endpoint [Срок оценки: around one month/before the time-corresponding treatment cycle (Visit_2)]
  • Immunological endpoint [Срок оценки: around three months/before the time-corresponding treatment cycle (Visit_3)]
  • Immunological endpoint [Срок оценки: Through study completion, an average of 2 year]
  • Clinical endpoint_PFS [Срок оценки: Through study completion, an average of 2 year]
  • Clinical endpoint_OS [Срок оценки: Through study completion, an average of 2 year]
  • Clinical endpoint_ORR [Срок оценки: Through study completion, an average of 2 year]
Вторичные конечные точки (7)
  • Myeloid Index Score (MIS) [Срок оценки: Through study completion, an average of 2 year]
  • Index score values [Срок оценки: Through study completion, an average of 2 year]
  • Transcriptional signatures_PBMC [Срок оценки: baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months)]
  • Transcriptional signatures_myeloid cells [Срок оценки: baseline, that is prior to start the therapy (Visit_1) or at the first disease evaluation (around after three months)]
  • Phospho-kinome signature result [Срок оценки: Through study completion, an average of 2 year]
  • Metabolomic profiles [Срок оценки: Through study completion, an average of 2 year]
  • Socio-Economical-Psychological (SEP) score [Срок оценки: Through study completion, an average of 2 year]

Критерии участия

Критерии включения

  • Histologically documented diagnosis of metastatic/locally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included
  • Will and ability to comply with the protocol
  • Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis
  • Age from 18 to 90 years at the time of recruitment
  • ECOG Performance Status <= 2
  • Understanding and signature of the informed consent
  • Consenting to participate to the socio-economical-psychological survey

Критерии исключения

  • Known history of HIV infection
  • Serious neurological or psychiatric disorders
  • Pregnancy or lactation
  • Inability or unwillingness of participant to give written informed consent
  • Inability or unwillingness to be regularly followed up at the same center

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 1 центр
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan

Публикации

  • Huber V, Vallacchi V, Fleming V, Hu X, Cova A, Dugo M, Shahaj E, Sulsenti R, Vergani E, Filipazzi P, De Laurentiis A, Lalli L, Di Guardo L, Patuzzo R, Vergani B, Casiraghi E, Cossa M, Gualeni A, Bollati V, Arienti F, De Braud F, Mariani L, Villa A, Altevogt P, Umansky V, Rodolfo M, Rivoltini L. Tumor-derived microRNAs induce myeloid suppressor cells and predict immunotherapy resistance in melanoma PMID 30260323
  • Ribas A, Wolchok JD. Cancer immunotherapy using checkpoint blockade. Science. 2018 Mar 23;359(6382):1350-1355. doi: 10.1126/science.aar4060. Epub 2018 Mar 22. PMID 29567705
  • Galluzzi L, Buque A, Kepp O, Zitvogel L, Kroemer G. Immunological Effects of Conventional Chemotherapy and Targeted Anticancer Agents. Cancer Cell. 2015 Dec 14;28(6):690-714. doi: 10.1016/j.ccell.2015.10.012. PMID 26678337
  • Apetoh L, Tesniere A, Ghiringhelli F, Kroemer G, Zitvogel L. Molecular interactions between dying tumor cells and the innate immune system determine the efficacy of conventional anticancer therapies. Cancer Res. 2008 Jun 1;68(11):4026-30. doi: 10.1158/0008-5472.CAN-08-0427. PMID 18519658
  • Peguillet I, Milder M, Louis D, Vincent-Salomon A, Dorval T, Piperno-Neumann S, Scholl SM, Lantz O. High numbers of differentiated effector CD4 T cells are found in patients with cancer and correlate with clinical response after neoadjuvant therapy of breast cancer. Cancer Res. 2014 Apr 15;74(8):2204-16. doi: 10.1158/0008-5472.CAN-13-2269. Epub 2014 Feb 17. PMID 24535711
  • Wilmott JS, Long GV, Howle JR, Haydu LE, Sharma RN, Thompson JF, Kefford RF, Hersey P, Scolyer RA. Selective BRAF inhibitors induce marked T-cell infiltration into human metastatic melanoma. Clin Cancer Res. 2012 Mar 1;18(5):1386-94. doi: 10.1158/1078-0432.CCR-11-2479. Epub 2011 Dec 12. PMID 22156613
  • Steinberg SM, Shabaneh TB, Zhang P, Martyanov V, Li Z, Malik BT, Wood TA, Boni A, Molodtsov A, Angeles CV, Curiel TJ, Whitfield ML, Turk MJ. Myeloid Cells That Impair Immunotherapy Are Restored in Melanomas with Acquired Resistance to BRAF Inhibitors. Cancer Res. 2017 Apr 1;77(7):1599-1610. doi: 10.1158/0008-5472.CAN-16-1755. Epub 2017 Feb 15. PMID 28202513
  • Spitzer MH, Carmi Y, Reticker-Flynn NE, Kwek SS, Madhireddy D, Martins MM, Gherardini PF, Prestwood TR, Chabon J, Bendall SC, Fong L, Nolan GP, Engleman EG. Systemic Immunity Is Required for Effective Cancer Immunotherapy. Cell. 2017 Jan 26;168(3):487-502.e15. doi: 10.1016/j.cell.2016.12.022. Epub 2017 Jan 19. PMID 28111070

Идентификаторы

NCT: NCT05621837 · INT 48/21

Первоисточники (государственные реестры)

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