Circulating DNA Analysis for Soft Tissue Sarcoma

Overseen By Albiruni Razak, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Prior malignancy, Metastases, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study circulating tumor DNA, a type of DNA found in the bloodstream that originates from soft tissue sarcoma tumors. Researchers seek to determine if this DNA can aid in cancer detection, predict treatment effectiveness, and monitor the disease over time. Participants will provide blood samples at various stages, such as before radiation treatment and after surgery. The process includes collecting archival tumor tissue and conducting blood draws. Suitable candidates for this trial have specific types of sarcoma, like liposarcoma or leiomyosarcoma, and plan to undergo radiation and surgery. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance cancer detection and treatment monitoring.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that circulating tumor DNA analysis is safe for patients with soft tissue sarcoma?

Research shows that a blood test called circulating tumor DNA (ctDNA) offers a promising way to monitor soft tissue sarcoma. This noninvasive test doesn't require surgery or other procedures that enter the body. Studies have found that ctDNA can track the disease and predict treatment effectiveness.

Regarding safety, this test poses low risk. It involves taking blood samples at different times, similar to a regular blood test, which is generally safe and easy to handle. Most people experience only minor side effects, such as a small bruise or slight discomfort at the needle site.

Overall, current research suggests that ctDNA analysis for soft tissue sarcoma is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about circulating DNA analysis for soft tissue sarcoma because it offers a non-invasive way to monitor cancer progression and response to treatment. Unlike traditional methods that rely heavily on imaging or repeated biopsies, this approach uses simple blood draws to detect changes in tumor DNA over time. This can potentially lead to earlier detection of recurrence and a more personalized treatment strategy, making it a promising development in the management of soft tissue sarcoma.

What evidence suggests that circulating tumor DNA analysis is effective for soft tissue sarcoma?

Research has shown that circulating tumor DNA (ctDNA) can help monitor diseases like soft tissue sarcoma. Studies have found ctDNA in the blood, making it useful for assessing treatment effectiveness. In this trial, participants will provide blood samples at various points to analyze ctDNA, enabling doctors to track cancer response without invasive procedures. Overall, ctDNA offers a noninvasive method to monitor cancer progress and adjust treatments as needed. ^{1 2 4 6 7}

Who Is on the Research Team?

Albiruni Razak, MD

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high-risk soft tissue sarcoma who are suitable for surgery and radiotherapy. They must have a performance status indicating they can care for themselves, have tumor tissue from a biopsy, and be able to consent to the study. Those with other recent cancers, metastases, serious illnesses affecting compliance or planned chemotherapy are excluded.

Inclusion Criteria

Patients must have archival tissue from the diagnostic biopsy available.

Ability to understand and willing to sign a written informed consent document and comply with study requirements.

I have a confirmed diagnosis of a high-risk sarcoma in my limbs or abdomen.

Exclusion Criteria

My cancer has spread to nearby lymph nodes or other parts of my body.

I have not had cancer in the last 5 years, except for skin or early cervical cancer.

I do not have any serious illnesses that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Blood and tumor tissue samples are collected for DNA testing

Prior to planned radiation treatment

1 visit (in-person)

Post-Surgery Monitoring

Blood samples are collected 2-4 weeks after cancer surgery

2-4 weeks

1 visit (in-person)

Long-term Follow-up

Blood samples are collected every 12 weeks after surgery for up to 2 years to monitor ctDNA levels

2 years

Every 12 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Archival tumor tissue collection and blood draws

Trial Overview The study is collecting blood samples and archival tumor tissues from patients to analyze circulating tumor DNA (ctDNA). This ctDNA may help in detecting cancer, predicting how well treatments might work, and monitoring the disease's progression during treatment.

How Is the Trial Designed?

Group I: Soft Tissue Sarcoma Experimental Treatment 1 Intervention

A sample of archival tumor tissue will be collected. Blood samples (about 20-30 mL or 1-2 tablespoons each sample) will be taken: * Prior to planned radiation treatment * 2-4 weeks after cancer surgery * Every 12 weeks after surgery for up to 2 years

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Mount Sinai Hospital, Canada

Collaborator

Trials

210

Recruited

70,700+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

Liquid biopsies, which analyze circulating tumor cells and circulating tumor DNA in blood, offer a promising alternative to traditional tissue biopsies for diagnosing and monitoring sarcomas, a rare and heterogeneous group of tumors.

While initial results for using liquid biopsies in sarcomas are encouraging, there are still technical challenges that need to be overcome before they can be widely implemented in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid Biopsies in Sarcoma Clinical Practice: Where Do We Stand? van der Laan, P., van Houdt, WJ., van den Broek, D., et al.[2023]

In a study of 24 advanced soft tissue sarcoma patients, circulating tumor DNA (ctDNA) was detected in 18, but the concordance between ctDNA and solid tumor genomic profiling was low, particularly for copy number alterations.

The highest concordance rates were observed in leiomyosarcoma patients, with a 76% agreement for short variant alterations when tumor fractions were detectable, suggesting that ctDNA profiling may not be broadly applicable for all sarcoma types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of the Concordance of Commercial Circulating Tumor DNA Alterations with Tumor-Based Sequencing across Multiple Soft Tissue Sarcoma Subtypes. Demoret, B., Gregg, J., Liebner, DA., et al.[2020]

Liquid biopsy presents a promising, minimally invasive alternative to traditional tissue biopsies for monitoring sarcomas, which are diverse and complex tumors, allowing for more accurate and dynamic assessment of the disease.

Recent advancements in liquid biopsy technologies have identified various blood-based tumor components, such as circulating tumor cells and cell-free nucleic acids, which could enhance precision medicine approaches in treating sarcoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of liquid biopsy in bone and soft tissue sarcomas: Present and future. Li, X., Seebacher, NA., Hornicek, FJ., et al.[2020]

In a study of 12 soft tissue sarcoma patients, structural variants were successfully detected in 91.6% of tissue samples and 50% of matched plasma samples using a sarcoma-specific targeted next generation sequencing (NGS) panel.

The findings suggest that circulating tumor DNA (ctDNA) analysis can be a valuable tool for diagnosing and monitoring sarcomas, indicating a need for further research in larger patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Structural Variants in Circulating Cell-Free DNA from Sarcoma Patients Using Next Generation Sequencing. Mc Connell, L., Gazdova, J., Beck, K., et al.[2020]

In a study of 64 patients with soft tissue sarcomas (STS), circulating free DNA (cfDNA) levels were significantly higher and more fragmented compared to patients in remission and healthy controls, indicating its potential as a diagnostic biomarker.

The study established sensitive assays to detect specific genetic alterations in circulating tumor DNA (ctDNA) for certain types of liposarcomas, which correlated with clinical outcomes and could help in monitoring tumor activity and detecting recurrences, suggesting a need for closer follow-up in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genotyping of circulating cell-free DNA enables noninvasive tumor detection in myxoid liposarcomas. Braig, D., Becherer, C., Bickert, C., et al.[2019]

The tumor biobank at the University of Siena has been crucial for cancer research since 1985, collecting a diverse range of biological samples such as DNA, RNA, tissues, and blood to enhance patient care.

This extensive collection of samples and clinical data supports the development of new strategies for cancer treatment, highlighting the importance of biobanks in advancing oncological research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a tumor bank: a thirty years experience of the University of Siena (Italy). Corso, G., Garosi, L., Marrelli, D., et al.[2015]

The study utilized the CellSieve™ microfiltration system to detect circulating tumor cells (CTCs) in both mouse models and human patients with high-grade sarcomas, showing that CTC presence correlates with disease burden and can indicate clinically silent metastases.

In human patients, CTCs were found at diagnosis and decreased with effective treatment, suggesting that monitoring CTC levels could help predict metastatic relapse even before visible symptoms appear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Size-based detection of sarcoma circulating tumor cells and cell clusters. Hayashi, M., Zhu, P., McCarty, G., et al.[2019]

In a study of 29 patients with various subtypes of soft tissue sarcomas (STS), circulating tumor DNA (ctDNA) was detected in only 17% of cases, indicating that while it may help track some patients, it is not consistently reliable for monitoring STS progression.

The analysis showed that perioperative cell-free DNA (cfDNA) levels were elevated but did not correlate with important clinical factors like tumor size or recurrence, suggesting limited diagnostic value for cfDNA in STS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Circulating Nucleic Acid Characteristics of Non-Metastatic Soft Tissue Sarcoma Patients. Eastley, N., Sommer, A., Ottolini, B., et al.[2021]

In a study involving 25 plasma samples from 3 patients with soft tissue sarcomas (STS), circulating tumor DNA (ctDNA) levels were found to correlate with tumor burden, allowing for early detection of recurrences and monitoring of treatment response.

The quantification of ctDNA showed that it could indicate minimal residual disease during remission and significantly decline after effective treatments, suggesting that it may help guide timely therapeutic decisions and potentially improve patient survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Mini-Panel Sequencing of ctDNA Allows Tumor Monitoring in Complex Karyotype Sarcomas. Braig, D., Runkel, A., Eisenhardt, AE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11941651/

Unlocking the Potential of ctDNA in Sarcomas - PubMed Central Circulating tumor DNA (ctDNA) has emerged as a promising noninvasive tool for disease monitoring, prognosis, and treatment response.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e23559

Correlation between circulating tumor DNA (ctDNA) and ... This pilot study aimed to evaluate the feasibility of detecting ctDNA in soft tissue sarcomas and how ctDNA correlates with radiologic surveillance.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11545914/

Investigating the Use of Circulating Tumor DNA for ... This study has demonstrated that personalized assays based on primary tumor-specific mutations can be used to detect ctDNA in the blood of sarcoma patients.

4. nature.com nature.com/articles/s41698-025-00876-y

Circulating tumor DNA to monitor treatment response in ... In this review, we provide a comprehensive, up-to-date summary of ctDNA in monitoring treatment response with a focus on lung, colorectal, and breast cancers.

5. karger.com karger.com/ort/article/48/4/186/918524/New-Insights-from-Long-Term-Clinical-Use-of

New Insights from Long-Term Clinical Use of Circulating ... This study investigates the emerging use of circulating tumor DNA (ctDNA) as a method to monitor the tumor burden in patients with a specific ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03818412

Circulating Tumor DNA in Soft Tissue Sarcoma This research study will collect blood and tumor tissue samples from patients with soft tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA).

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11577

Enhancing soft tissue sarcoma surveillance: The role of ... Our study demonstrates the potential utility of ctDNA testing in monitoring high-risk STS patients. ctDNA showed no significant difference in time to ...