Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07432932
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent for the prospective cohort
* Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.
* High-risk sarcoma definition:
* Greater than 5cm or Grade 3
* Deep anatomic location
* Have disease amenable to biopsy
o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study
* Resectable tumour
* Measurable disease by RECIST 1.1
* Aged ≥ 18 years
* WHO performance status 0-2
* For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy
* Patients medically fit enough to undergo surgical resection
* Capable of giving written informed consent (for prospective cohort) and comply with the study schedule
* Patients may also participate in the STRASS 2 trial
Exclusion Criteria:
-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI.
* Known additional malignancy that is progressing or requires active treatment
* Metastatic disease not amenable to curative intent local therapy
* Any active uncontrolled medical conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07432932
Study Brief:
Protocol Section:
NCT07432932