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

NCT06385288 | Recruiting

• 1 other identifier: 268/2021BO2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma Adult

Keywords

Soft tissue sarcomas; immunological examinations; neoadjuvant therapy; radiotherapy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

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

  Weekly MRIs during neoadjuvant radiation therapy

  5 years of recruitment, 5 years follow-up

Study Arms (1)

Single-arm trial

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.

Other: Blood and tissue collection for immunological studies, advanced imaging.; Other: neoadjuvant Therapy

Interventions

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.

Single-arm trial

neoadjuvant Therapy OTHER

neoadjuvant Therapy

Single-arm trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Blood Specimen Collection; Tissue Banks; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services; Combined Modality Therapy; Therapeutics

Central Study Contacts

Franziska Eckert, MD, Prof.

CONTACT

+49 7071 29; franziska.eckert@med.uni-tuebingen.de

Vlatko Potkrajcic, MD

CONTACT

+49 7071 29; Vlatko.potkrajcic@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: April 26, 2024
• Study Start: July 21, 2021
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2031
• Last Updated: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)