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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-21

Study Completion Date

2030-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Studying Tumor Tissue Samples From Patients With Soft Tissue Sarcoma

NCT00900341

Sarcoma

COMPLETED

Circulating Tumor DNA in Soft Tissue Sarcoma

NCT03818412

Soft Tissue Sarcoma

RECRUITING NA

Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma

NCT03896620

Sarcoma

RECRUITING

Genetic and Telomere Characteristics of High of Grade Soft Tissue Sarcomas

NCT02547376

Soft Tissue Sarcoma

TERMINATED

Circulating Tumor DNA As Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study At MUSC HCC

NCT03302325

Solid Tumor, Adult

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Non-Metastatic and Resectable

Intervention Type 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

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

Metastatic and Un-resectable

Intervention Type 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

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

No evidence of disease, under surveillance

Intervention Type 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

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

ALT or WDLS

Intervention Type OTHER

Blood Draw Timepoints:

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Metastatic and Un-resectable

Blood Draw Timepoints:

* Before any treatment begins
* During standard of care disease evaluation visits for up to 24 months

Intervention Type OTHER

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

Intervention Type OTHER

ALT or WDLS

Blood Draw Timepoints:

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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