Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The purpose of this research study is to see how well Low Pass Whole Genome Sequencing (LP-WGS) can detect circulating tumor deoxyribonucleic acid (ctDNA) in the blood of participants who have bone or soft tissue sarcoma (type of cancer).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Written informed consent or assent when applicable from the participant, LAR, parent or legal guardian and HIPAA authorization for release of personal health information.

• All ages allowed

• Suspected or confirmed disease (must meet one of the criteria below):

‣ Suspected bone or soft tissue tumor concerning for sarcoma (pending confirmation of sarcoma diagnosis)

‣ OR

⁃ Suspected lipomatous mass concerning for ALT or WDLS with planned surgery

‣ OR

⁃ Confirmed bone or soft tissue sarcoma meeting one of the criteria below:

• Non-metastatic/Resectable sarcoma with either planned or currently receiving therapy

∙ Metastatic or unresectable sarcoma, with planned or currently receiving therapy

∙ Non-metastatic sarcoma under surveillance with no more than 1 year from completion of therapy

Locations
United States
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
Contact Information
Primary
Meg Lattanze
Megan.Lattanze@advocatehealth.org
980-442-4239
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2030-01
Participants
Target number of participants: 300
Treatments
Non-Metastatic and Resectable
Cohort A1: Non-metastatic/ Resectable (with planned or you are undergoing therapy)- your cancer has not spread, may be able to remove it with operation
Metastatic and Un-resectable
Cohort A2: Metastatic/ Unresectable (with planned or you are undergoing therapy)- your cancer has spread, not able to operate at this time to take out all the cancer
No evidence of disease, under surveillance
Cohort B: No evidence of disease/ surveillance (you have completed initial therapy)- currently there is no evidence of your cancer/disease and you are under surveillance, meaning your physician is checking your medical situation at intervals or occasionally for any sign of changes
ALT or WDLS
Cohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma)
Related Therapeutic Areas
Sponsors
Collaborators: Paula Takacs Foundation
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov