Analyzing blood samples for tumor DNA in soft tissue sarcoma patients
Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)
This study is testing if blood samples from soft tissue sarcoma patients can help find tumor DNA to see if it can predict how likely the cancer is to come back after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03818412 on ClinicalTrials.gov |
What this trial studies
This research focuses on collecting blood and tumor tissue samples from patients diagnosed with soft tissue sarcoma to investigate circulating tumor DNA (ctDNA). ctDNA is released into the bloodstream when tumor cells die, and it serves as a crucial biomarker for cancer detection, treatment response prediction, and disease monitoring. The study aims to assess the feasibility of detecting ctDNA in blood samples and to explore its correlation with the likelihood of disease recurrence after treatment. By understanding these biomarkers, researchers hope to improve cancer care and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with high-risk extremity or retroperitoneal liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma who have available archival tissue from their diagnostic biopsy.
Not a fit: Patients with benign tumors, prior malignancies within the last five years, or those requiring neo-adjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to monitor soft tissue sarcoma and predict treatment responses, leading to better patient management.
How similar studies have performed: Other studies have shown promise in using circulating tumor DNA as a biomarker in various cancers, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have histologically confirmed high-risk extremity or retroperitoneal liposarcoma, leiomyosarcoma and undifferentiated pleomorphic sarcoma. * Patients must have archival tissue from the diagnostic biopsy available. * Deemed appropriate for preoperative or postoperative radiotherapy and curative surgery following patient assessment by radiation oncologist and surgical oncologist. * Age 18 years or older. * Eastern Cooperative Group (ECOG) performance status ≤ 2 * Ability to understand and willing to sign a written informed consent document and comply with study requirements. Exclusion Criteria: * Patients with benign histology * Patients with prior malignancy within previous 5 years or concurrent malignancy other than adequately treated basal cell carcinoma of skin or carcinoma in-situ of cervix. * Patients with planned neo-adjuvant chemotherapy. * Patients with regional nodal disease or unequivocal metastases * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Albiruni Razak, M.D. — Princess Margaret Cancer Centre
- Study coordinator: Albiruni Razak, M.D.
- Email: albiruni.razak@uhn.ca
- Phone: 416-946-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.