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

Soft Tissue Sarcoma Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385288
• Other study ID #: 268/2021BO2
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: July 21, 2031

Study information

• Verified date: July 2023
• Source: University Hospital Tuebingen
• Contact: Franziska Eckert, MD, Prof.
• Phone: +49 7071 29
• Email: franziska.eckert[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

"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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 21, 2031
• Est. primary completion date: July 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma Adult

Intervention

Other:
• 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.
• neoadjuvant Therapy
neoadjuvant Therapy

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years of recruitment, 5 years follow-up
Primary	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	5 years of recruitment, 5 years follow-up
Primary	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.	5 years of recruitment, 5 years follow-up
Primary	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.	5 years of recruitment, 5 years follow-up
Primary	Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs	Weekly MRIs during neoadjuvant radiation therapy	5 years of recruitment, 5 years follow-up