SarcomaNCT03896620
Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
An observational study of Sarcoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
A tissue biopsy is currently the only clinical test or procedure that is able to confirm the initial diagnosis of soft tissue or metastatic sarcoma and evaluate its progress during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Preoperative RT, Postoperative RT and Chemotherapy
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 1 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with localized, stage II-III or stage IV histologically confirmed soft tissue sarcomas of the extremity, chest wall or retroperitoneal primaries will be eligible for this study. Stage IV patients may have had prior therapy but must obtain a biopsy within registration requirements for study enrollment.
Who may be able to join
- Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation.
- Diagnosis of soft tissue sarcoma.
- ≥ 18 years of age.
- Planned biopsy obtained within four weeks after registration.
- History and physical within eight weeks prior to registration.
- For stage II-III patients, no prior therapy to primary site of sarcoma.
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- Computerized tomography (CT), positron emission tomography (PET) /CT or MR imaging of the affected primary site obtained in stage II-III or metastatic site in stage IV patients within eight weeks prior to registration.
- CT chest or PET /CT acquired to assess distant disease within eight weeks prior to registration for stage II-III patients.
- Karnofsky Performance Scale (KPS) 60 or above within four weeks prior to registration.
- Documentation of stage within eight weeks prior to registration.
- Biopsy of primary or metastatic disease site must be safe, feasible and in concordance with standard of care per the treating physician and/or radiologist.
- Life expectancy ≥ 12 weeks.
Who cannot join
- Pregnant women.
- Patients with a history of metastatic disease from a primary other than sarcoma.
- Patients who cannot undergo imaging as part of treatment planning or surveillance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
A tissue biopsy is currently the only clinical test or procedure that is able to confirm the initial diagnosis of soft tissue or metastatic sarcoma and evaluate its progress during treatment. However, tissue biopsy collection can be challenging (depending on the location of the tumor), and this procedure poses physical risks to the patient. A tissue biopsy also needs to be recollected at various time points in order to assess if the patient is responding to treatment.
In this project, the investigator would like to collect blood samples in addition to the sample of the tumor that will be collected before treatment is started. The investigator would like to analyze both blood and tumor, in hopes of identifying new biomarkers of sarcoma that can help the study doctors better diagnose sarcoma for patients in the future without needing to collect a piece of their tumor.
A biomarker is something found in the blood, other body fluids, or tissues that can be used to measure the progress of disease, how a treatment is working, or its likelihood of being successful. In this project, the investigator would like to compare ctDNA from blood to the DNA in the tumor. ctDNA, or circulating tumor DNA, is DNA originating from the tumor that is present in the blood. It can be assessed by taking an additional sample of blood when it will be collected for normal laboratory tests. These biomarkers may also help the study doctors detect how a patient is responding to their treatment or help predict their response to future treatment.
Read the detailed description
In the proposed study, the investigators wish to prospectively collect blood samples from 25 patients with localized soft tissue sarcomas and 25 patients with metastatic sarcoma (schema III) at various time points outlined. The presence/absence, as well as the change of ctDNA in circulation, will then be measured after the therapies administered and correlated with overall survival, progression-free survival and local control.
The risks to the subjects enrolled on this study include the general risks of undergoing the standard procedures, such as blood draws, imaging, radiation therapy, chemotherapy and surgery, which will be discussed prior to the therapies and images each patient undergoes. The risks of the procedures are not risks of the study with exception to blood draws. There is also a risk of loss of confidentiality, but the data will be deidentified once acquired. Thus, this risk is minimal.
- Conditions
- Sarcoma
- Being tested
- Preoperative RT, Postoperative RT, Chemotherapy, Surgery
- Keywords
- Sarcoma, ctDNA
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative RTDevice
Radiation delivered before surgery.
Postoperative RTDevice
Radiation delivered after surgery.
ChemotherapyDrug
Physician's choice of chemotherapy.
SurgeryOther
Surgical excision of tumor.
| Study group | Role | What they receive |
|---|---|---|
| Stage II-III Sarcomas undergoing preoperative radiation therapy (RT) | This group will have preoperative chemotherapy (if administered), preoperative radiation and surgery. Receives: Device: Preoperative RT; Drug: Chemotherapy; Other: Surgery | |
| Stage II-III Sarcomas undergoing postoperative RT | This group will have surgery, postoperative radiation, post operative chemotherapy (if administered). Receives: Device: Postoperative RT; Drug: Chemotherapy; Other: Surgery | |
| Stage IV Sarcomas | This group will only have chemotherapy. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA measure
Blood samples will be collected. ctDNA is measured in percentage: variant allele fraction percentage.
Measured: Reported at baseline, at 4 weeks after first intervention, 4 weeks following radiation treatment, 4 weeks post third intervention, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start18 Jun 2019
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (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 Medical College of WisconsinThe 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
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciani M Ellison, MD, Medical College of Wisconsin
- Investigators
- Ciani Ellison, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896620
- Sponsor's protocol ID
- PRO00034441
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2019
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition of Circulating Tumor DNA in Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03896620
- Acronym / sponsor ID
- PRO00034441
- Conditions
- Sarcoma
- Keywords
- Sarcoma, ctDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Apr 2019 (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.
A tissue biopsy is currently the only clinical test or procedure that is able to confirm the initial diagnosis of soft tissue or metastatic sarcoma and evaluate its progress during treatment. However, tissue biopsy collection can be challenging (depending on the location of the tumor), and this procedure poses physical risks to the patient. A tissue biopsy also needs to be recollected at various time points in order to assess if the patient is responding to treatment.
In this project, the investigator would like to collect blood samples in addition to the sample of the tumor that will be collected before treatment is started. The investigator would like to analyze both blood and tumor, in hopes of identifying new biomarkers of sarcoma that can help the study doctors better diagnose sarcoma for patients in the future without needing to collect a piece of their tumor.
A biomarker is something found in the blood, other body fluids, or tissues that can be used to measure the progress of disease, how a treatment is working, or its likelihood of being successful. In this project, the investigator would like to compare ctDNA from blood to the DNA in the tumor. ctDNA, or circulating tumor DNA, is DNA originating from the tumor that is present in the blood. It can be assessed by taking an additional sample of blood when it will be collected for normal laboratory tests. These biomarkers may also help the study doctors detect how a patient is responding to their treatment or help predict their response to future treatment.
Detailed description
In the proposed study, the investigators wish to prospectively collect blood samples from 25 patients with localized soft tissue sarcomas and 25 patients with metastatic sarcoma (schema III) at various time points outlined. The presence/absence, as well as the change of ctDNA in circulation, will then be measured after the therapies administered and correlated with overall survival, progression-free survival and local control.
The risks to the subjects enrolled on this study include the general risks of undergoing the standard procedures, such as blood draws, imaging, radiation therapy, chemotherapy and surgery, which will be discussed prior to the therapies and images each patient undergoes. The risks of the procedures are not risks of the study with exception to blood draws. There is also a risk of loss of confidentiality, but the data will be deidentified once acquired. Thus, this risk is minimal.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage II-III Sarcomas undergoing preoperative radiation therapy (RT) | – | Device: Preoperative RT, Drug: Chemotherapy, Other: SurgeryThis group will have preoperative chemotherapy (if administered), preoperative radiation and surgery. |
| Stage II-III Sarcomas undergoing postoperative RT | – | Device: Postoperative RT, Drug: Chemotherapy, Other: SurgeryThis group will have surgery, postoperative radiation, post operative chemotherapy (if administered). |
| Stage IV Sarcomas | – | Drug: ChemotherapyThis group will only have chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized, stage II-III or stage IV histologically confirmed soft tissue sarcomas of the extremity, chest wall or retroperitoneal primaries will be eligible for this study. Stage IV patients may have had prior therapy but must obtain a biopsy within registration requirements for study enrollment.
Key inclusion criteria (12 listed)
- Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation.
- Diagnosis of soft tissue sarcoma.
- ≥ 18 years of age.
- Planned biopsy obtained within four weeks after registration.
- History and physical within eight weeks prior to registration.
Key exclusion criteria (3 listed)
- Pregnant women.
- Patients with a history of metastatic disease from a primary other than sarcoma.
- Patients who cannot undergo imaging as part of treatment planning or surveillance.
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 |
|---|---|---|
| Preoperative RTRadiation delivered before surgery. | Device | Stage II-III Sarcomas undergoing preoperative radiation therapy (RT) |
| Postoperative RTRadiation delivered after surgery. | Device | Stage II-III Sarcomas undergoing postoperative RT |
| ChemotherapyPhysician's choice of chemotherapy. | Drug | Stage II-III Sarcomas undergoing postoperative RT, Stage II-III Sarcomas undergoing preoperative radiation therapy (RT), Stage IV Sarcomas |
| SurgerySurgical excision of tumor. | Other | Stage II-III Sarcomas undergoing postoperative RT, Stage II-III Sarcomas undergoing preoperative radiation therapy (RT) |
Primary outcome
ctDNA measure
Time frame: Reported at baseline, at 4 weeks after first intervention, 4 weeks following radiation treatment, 4 weeks post third intervention, 1 year.
Blood samples will be collected. ctDNA is measured in percentage: variant allele fraction percentage.
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ciani Ellison, MD principal investigator
Medical College of Wisconsin
1 site 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 Medical College of Wisconsin at 1 site 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 12 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA measure (time frame: Reported at baseline, at 4 weeks after first intervention, 4 weeks following radiation treatment, 4 weeks post third intervention, 1 year.). 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 23 Jun 2026.