SarcomaNCT06958107
LCI-SAR-BSTS-CTDNA-001: Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Sarcoma Patients
An observational study of Sarcoma, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- Non-Metastatic and Resectable, Metastatic and Un-resectable and No evidence of disease, under surveillance
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2025to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of all ages with concern for or diagnosed with bone or soft tissue sarcoma or lipomatous mass will be identified by treatment investigators in oncology clinics treatment patients with sarcoma
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Meg Lattanze, 980-442-4239, Megan.Lattanze@advocatehealth.org
Johann Hsu, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27103
Shailaja Raj, 336-716-7970, sraj@wakehealth.edu
About this study
Official title: Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Patients With Sarcoma
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). This study is also looking at a new technology called Rametrix® Molecular urinalysis (RMU). The study is using this technology to evaluate changes in the urine that may indicate the presence of disease or cancer.
Read the detailed 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 longitudinal liquid biopsy and urine sample approaches in adult and pediatric patients with bone and soft tissue sarcomas.
- Conditions
- Sarcoma
- Being tested
- Non-Metastatic and Resectable, Metastatic and Un-resectable, No evidence of disease, under surveillance, ALT or WDLS
- Keywords
- circulating tumor DNA, liquid biopsy, bone or soft tissue Sarcoma, spectroscopy-based molecular urinalysis
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Metastatic and ResectableOther
Blood Draw \& Urine 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 standard of care disease evaluation visits: at Months 3, 6, 9, 12, 15, 18, and 24
- Once 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-resectableOther
Blood Draw \& Urine Timepoints:
- Before any treatment begins
- During standard of care disease evaluation visits for up to 24 months
No evidence of disease, under surveillanceOther
Blood Draw \& Urine 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 WDLSOther
Blood Draw Timepoints:
- Collect only blood once after surgery (up to six weeks after surgery)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Non-Metastatic and Resectable | |
| 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 Receives: Other: Metastatic and Un-resectable | |
| 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 Receives: Other: No evidence of disease, under surveillance | |
| ALT or WDLS | Cohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma) Receives: Other: ALT or WDLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ctDNA detected
A binary variable indicating whether or not ctDNA was detected by low pass whole genome sequencing (LP-WGS) in the sample.
Measured: Approximately 24 months
Secondary outcomes (1)
Quantity of ctDNA detected
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)
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start21 Aug 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Paula Takacs Foundation
- Responsible party
- Sponsor
- Investigators
- Johann Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958107
- Sponsor's protocol ID
- IRB00127078
- Other IDs
- LCI-SAR-BSTS-CTDNA-001
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of Circulating Tumor DNA Liquid Biopsy and Spectroscopy-based Molecular Urinalysis in Patients With Sarcoma
- ClinicalTrials.gov ID
- NCT06958107
- Acronym / sponsor ID
- IRB00127078
- Conditions
- Sarcoma
- Keywords
- circulating tumor DNA, liquid biopsy, bone or soft tissue Sarcoma, spectroscopy-based molecular urinalysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Paula Takacs Foundation
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). This study is also looking at a new technology called Rametrix® Molecular urinalysis (RMU). The study is using this technology to evaluate changes in the urine that may indicate the presence of disease or cancer.
Detailed 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 longitudinal liquid biopsy and urine sample approaches in adult and pediatric patients with bone and soft tissue sarcomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Metastatic and Resectable | – | Other: Non-Metastatic and ResectableCohort 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 | – | Other: Metastatic and Un-resectableCohort 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 | – | Other: No evidence of disease, under surveillanceCohort 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 | – | Other: ALT or WDLSCohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages with concern for or diagnosed with bone or soft tissue sarcoma or lipomatous mass will be identified by treatment investigators in oncology clinics treatment patients with sarcoma
Key inclusion criteria (11 listed)
- 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):
- OR
- OR
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Metastatic and ResectableBlood Draw \& Urine 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 standard of care disease evaluation visits: at Months 3, 6, 9, 12, 15, 18, and 24 * Once 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 | Other | Non-Metastatic and Resectable |
| Metastatic and Un-resectableBlood Draw \& Urine Timepoints: * Before any treatment begins * During standard of care disease evaluation visits for up to 24 months | Other | Metastatic and Un-resectable |
| No evidence of disease, under surveillanceBlood Draw \& Urine 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 | Other | No evidence of disease, under surveillance |
| ALT or WDLSBlood Draw Timepoints: • Collect only blood once after surgery (up to six weeks after surgery) | Other | ALT or WDLS |
Primary outcome
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.
1 secondary outcome
Quantity of ctDNA detected
Time frame: Approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johann Hsu, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meg Lattanze (980-442-4239, Megan.Lattanze@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ctDNA detected (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.