Circulating Tumor DNA in Soft Tissue Sarcoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Archival tumor tissue collection and blood draws

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Soft Tissue SarcomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Duration from time of study trial until end

Time frame
5 years

Secondary outcomes

1

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

Duration from time of study trial until end

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Mount Sinai Hospital, Canada

Collaborator

The Hospital for Sick Children

Collaborator