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

Conditions

• Sarcoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Non-Metastatic and Resectable — OTHER
  Blood Draw Timepoints: * Before any treatment begins * After Neo-adjuvant therapy (only if you receive this type of therapy) * After local surgery * After Adjuvant therapy (only if you receive this type of therapy) * Follow up after adjuvant therapy: at Months 3, 6, 9, 12, 15, 18, and 24 * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis
• Metastatic and Un-resectable — OTHER
  Blood Draw Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months
• No evidence of disease, under surveillance — OTHER
  Blood Draw Timepoints: * From completion of treatment- at Months 3, 6, 9, 12, 15, 18, and 24; depending on when you enroll into the study you will start at the next timepoint in this schedule * After evidence of recurrence or worsening of disease, and then collected at standard of care disease evaluation visits up until 24 months from the last treatment for the initial diagnosis
• ALT or WDLS — OTHER
  Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery)

Study Details

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).

Key Dates

Start date

Aug 21, 2025

Status verified

Jan 2026

Primary completion

Jan 31, 2030

Completion

Jan 31, 2030

Study Design

Enrollment

300 participants (estimated)

Arms

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

Primary Outcome Measure

Number of participants with ctDNA detected [ Time Frame: Approximately 24 months ]

Central Contacts

• Meg Lattanze
  980-442-4239
  [email protected]

Locations (2)

Find similar trials in Charlotte, NC

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