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NCT Number: NCT06385288

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

"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.

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Key information

Conditions

Soft Tissue Sarcoma Adult Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Age < 18 years
  • Poor understanding (language etc.)
  • Lack of reconnaissance ability

Treatment and study plan

Blood and tissue collection for immunological studies, advanced imaging.

Other

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.

Neoadjuvant Therapy

Other

neoadjuvant Therapy

Primary outcomes

  1. Description of the cellular immune status via flow-cytometrie from collected blood samples

    Time frame: 5 years of recruitment, 5 years follow-up

    Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery.

  2. Description of the cellular immune status on tissue samples ussing komplex immunohistochemie

    Time frame: 5 years of recruitment, 5 years follow-up

    Tissue samples are taken as incisional biopsie as well as in the tumor tissue after the surgery

  3. Measurement of the cellular free DNA from collected blood samples

    Time frame: 5 years of recruitment, 5 years follow-up

    Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery.

  4. Measurement of HMGB1 from collected blood samples

    Time frame: 5 years of recruitment, 5 years follow-up

    Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery.

  5. Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs

    Time frame: 5 years of recruitment, 5 years follow-up

    Weekly MRIs during neoadjuvant radiation therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska Eckert, MD, Prof.

CONTACT

[email protected]

+49 7071 29 ext. 82165

Vlatko Potkrajcic, MD

CONTACT

[email protected]

+49 7071 29 ext. 82165

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Apr 26, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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