LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy in Sarcoma Patients

Wake Forest University (WFU)

Status: Enrolling

Conditions: Sarcoma

Treatments: Other: No evidence of disease, under surveillance; Other: Non-Metastatic and Resectable; Other: ALT or WDLS; Other: Metastatic and Un-resectable

Study type: Observational

Funder types: Other

Identifiers

NCT06958107

LCI-SAR-BSTS-CTDNA-001 (Other Identifier)

IRB00127078

Details and patient eligibility

About

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).

Full description

In this ever-expanding age of precision oncology, the stagnant treatment algorithms and subsequent oncologic outcomes for sarcoma patients highlight the need for novel technologies to help clinicians treat these patients. While countless prognostic and therapeutic molecular biomarkers have been identified for many other cancers, sarcoma practitioners have strikingly few tumor markers to guide treatment. The development of a sarcoma-specific liquid biopsy could greatly help clinicians with diagnosis, prognostication, treatment response, minimal recurrent disease, and recurrence. The purpose of this study is to clinically evaluate ctDNA liquid biopsy approaches in adult and pediatric patients with bone and soft tissue sarcomas.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

2. All ages allowed

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

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

      OR

   2. Suspected lipomatous mass concerning for ALT or WDLS with planned surgery

      OR

   3. 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

Exclusion criteria

• none

Trial design

300 participants in 4 patient groups

Non-Metastatic and Resectable

Description:

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

Treatment:

Other: Non-Metastatic and Resectable

Metastatic and Un-resectable

Description:

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

Treatment:

Other: Metastatic and Un-resectable

No evidence of disease, under surveillance

Description:

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

Treatment:

Other: No evidence of disease, under surveillance

ALT or WDLS

Description:

Cohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma)

Treatment:

Other: ALT or WDLS