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NCT Number: NCT06958107

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

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).

Recruiting

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Observational

Primary location

Levine Cancer Institute, Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • none

Treatment and study plan

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)

Primary outcomes

  1. Number of participants with ctDNA detected

    Time frame: Approximately 24 months

    A binary variable indicating whether or not ctDNA was detected by low pass whole genome sequencing (LP-WGS) in the sample.

Secondary outcomes

  1. Quantity of ctDNA detected

    Time frame: Approximately 24 months

    A longitudinal continuous variable indicating the quantitative levels of ctDNA in the sample as measured by LP-WGS. Timepoints include pre-treatment, at disease evaluations during treatment, post-treatment, at remission/complete response (if applicable), during surveillance (if applicable), and at recurrence/progression (if applicable)

Study contacts

Contact information is provided by the study sponsor or research team.

Meg Lattanze

CONTACT

[email protected]

980-442-4239

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Paula Takacs Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 6, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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