Circulating Tumor DNA in Soft Tissue Sarcoma

NCT03818412 | Recruiting

• 1 other identifier: DNA-TSAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Circulating tumor DNA

Outcome Measures

Primary Outcomes (1)

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

  Duration from time of study trial until end

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

Soft Tissue Sarcoma

EXPERIMENTAL

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

Procedure: Archival tumor tissue collection and blood draws

Interventions

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.

Soft Tissue Sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Mount Sinai Hospital, Canada: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Albiruni Razak, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albiruni Razak, M.D.

CONTACT

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

Pernille Pedersen, R.N.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: January 17, 2019
• Primary Completion: December 17, 2024
• Study Completion: January 17, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CA (1)