Recruiting

Low Pass Whole Genome Sequencing

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06958107

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-Metastatic and Resectable

Metastatic and Un-resectable

No evidence of disease, under surveillance

ALT or WDLS

Study Details

Brief 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).

Conditions

Sarcoma

Study ID

NCT06958107

Start date

Aug 21, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

Non-Metastatic and Resectable

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

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

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

Blood Draw Timepoints:

• Collect once after surgery (up to six weeks after surgery)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Meg Lattanze

980-442-4239Megan.Lattanze@advocatehealth.org

Locations

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Meg Lattanze

980-442-4239Megan.Lattanze@advocatehealth.org

Principal Investigator:

Johann Hsu, MD

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Shailaja Raj

336-716-7970sraj@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • circulating tumor DNA
  • liquid biopsy
  • bone or soft tissue Sarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-23.