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NCT Number: 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). 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Researchers are continually looking for ways to understand the biology of cancer such as sarcoma, and ways to improve cancer care and patient outcome.

Research has shown that changes in some genes and/or proteins, called biomarkers, may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and what this means for certain treatments.

Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response and disease monitoring. 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. Researchers are looking for better ways to detect circulating tumor DNA so that it can be studied.

The purpose of this study is to determine how feasible it is to detect circulating tumor DNA in blood samples of soft tissue sarcoma patients and whether there is a connection between circulating tumor DNA and the likelihood of patients' disease coming back after they receive treatment. To do this, blood and tumor tissue samples will be collected from participants and will undergo DNA testing (reading the contents of their DNA, called sequencing). The results of the DNA testing in the blood samples will be compared with the results from DNA testing that will also be done on tumor tissue. The results will also be compared with participant's response to their treatment, recurrence, and/or long term survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Archival tumor tissue collection and blood draws

Procedure

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

Primary outcomes

  1. Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification

    Time frame: 5 years

    Duration from time of study trial until end

Secondary outcomes

  1. Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence

    Time frame: 5 years

    Duration from time of study trial until end

Study contacts

Contact information is provided by the study sponsor or research team.

Albiruni Razak, M.D.

CONTACT

[email protected]

416-946-2000

Pernille Pedersen, R.N.

CONTACT

[email protected]

416-946-4501 ext. 2502

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Mount Sinai Hospital, Canada
  • The Hospital for Sick Children

Registry information

Official study title

Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2019
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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