Recruiting

Circulating Tumor DNA

Sponsor:

University Health Network, Toronto

Code:

NCT03818412

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Archival tumor tissue collection and blood draws

Study Details

Brief summary:

This research study will collect blood and tumor tissue samples from patients with soft tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA). When tumor cells are damaged or die, DNA from the tumor cells are released into the blood stream as the cells break down. This is called circulating tumor DNA. Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response, and disease monitoring.

Conditions

Soft Tissue Sarcoma

Study ID

NCT03818412

Start date

Jan 17, 2019

Status verified date

Jun, 2026

Completion date

Dec 17, 2026

Anticipated

Primary completion date

Dec 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Soft Tissue Sarcoma

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

Interventions

Archival tumor tissue collection and blood draws

Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.

Primary outcome measure

  • Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Albiruni Razak, M.D.

416-946-2000albiruni.razak@uhn.ca

Pernille Pedersen, R.N.

416-946-4501pernille.pederson@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Albiruni Razak, M.D.

416-946-2000albiruni.razak@uhn.ca

Limore Arones, R.N.

416-946-4501limore.arones@uhn.ca

Principal Investigator:

Albiruni Razak, M.D.

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Circulating tumor DNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-23.