Идёт набор NCT06385288

Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas

Без фазы С лечением Soft Tissue Sarcoma Adult

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: Blood and tissue collection for immunological studies, advanced imaging., neoadjuvant Therapy.
Кому может быть актуально: Состояния в реестре: Soft Tissue Sarcoma Adult. Базовые параметры: от 18 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

"Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging.

Подробное описание

All patients (\> 18 Years) with histologically confirmed high-risk soft tissue sarcoma eligible for neoadjuvant multimodal therapy (including radiotherapy +/- concomitant and sequential chemotherapy +/- hyperthermia as well as surgery) are screened for the study. Neoadjuvant therapy consists of 50-50.4 Gy in 25-28 fractions. Additional concomitant or sequential chemotherapy may be applied in selected cases (young patients, high-grade tumors). Additional hyperthermia concomitant to neoadjuvant radiotherapy is applied in selected cases if not contraindicated.

Preoperative tissue sampling to generate primary tumor cell lines in additional translational research is performed in each patient with a lesion suspect for soft tissue sarcoma and eligible for multimodal therapy. Primary cell lines are analyzed biologically (growth pattern, radioresistance, migration, molecular markers RT-PCR, immunological properties such as immunogenic cell death, lysis by cellular immunotherapies such as CAR-NK cells. Postoperative tumor tissues are additionally analyzed for immune cell mapping using complex immunohistochemistry. Biopsy and resection should include proteome analysis and DNA sequencing (only of the tumor tissue, not normal tissue).

Additional immunological monitoring (including cellular immune status, serum marker e.g. cell free DNA, HMGB1) is performed using blood sampling with in total 4 blood controls (25 ml each, before neoadjuvant radiotherapy, during the second and last week of radiotherapy as well as before surgery). In patients treated with concomitant MR-guided hyperthermia, weekly MR-imagine is performed.

Follow-up is carried out as part of the oncological controls over 5 years. The overall study is planned over a period of 5 years (interventional part), additional 5 years follow-up period.

Вмешательства

Другое Blood and tissue collection for immunological studies, advanced imaging.
Blood and tissue collection for immunological studies under neoadjuvant Therapy of soft tissue sarcomas. Prospective data collection and translational accompanying research on standard therapy. Use of tissue, blood samples and advanced imaging.
Другое neoadjuvant Therapy
neoadjuvant Therapy

Первичные конечные точки

Description of the cellular immune status via flow-cytometrie from collected blood samples [Срок оценки: 5 years of recruitment, 5 years follow-up]
Description of the cellular immune status on tissue samples ussing komplex immunohistochemie [Срок оценки: 5 years of recruitment, 5 years follow-up]
Measurement of the cellular free DNA from collected blood samples [Срок оценки: 5 years of recruitment, 5 years follow-up]
Measurement of HMGB1 from collected blood samples [Срок оценки: 5 years of recruitment, 5 years follow-up]
Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs [Срок оценки: 5 years of recruitment, 5 years follow-up]

Критерии участия

Критерии включения

Planned histological confirmation for especially high-risk soft tissue sarcoma via open Sampling
Indication for neoadjuvant multimodal therapy (radiation and locoregional Hyperthermia, optionally with simultaneous chemotherapy)
Planned resection of a department of the CWS
Age > 18 years
Ability to consent
Additionally for imaging study: Treatment on the combined MR hyperthermia device