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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen

About this trial

"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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

Poor understanding (language etc.)

Lack of reconnaissance ability

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood and tissue collection for immunological studies, advanced imaging.

    Other intervention

    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 intervention

    neoadjuvant Therapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single-arm trialOther 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
5 years of recruitment, 5 years follow-up
2

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

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

Time frame
5 years of recruitment, 5 years follow-up
3

Measurement of the cellular free DNA from collected blood samples

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

Time frame
5 years of recruitment, 5 years follow-up
4

Measurement of HMGB1 from collected blood samples

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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